Systems, methods and apparatus for delivering nerve stimulation to a patient with physician oversight

ABSTRACT

The present invention provides devices, systems and methods for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient. In some embodiments, the present invention provides a vestibular stimulation device configured both to generate a prescription for delivering one or more thermal waveforms and to deliver the prescribed thermal waveforms.

RELATED APPLICATIONS

This application is a 35 U.S.C. §371 national phase entry of PCTApplication No. PCT/US2011/065456, filed Dec. 16, 2011 and published inEnglish on Jun. 21, 2012 as International Publication No. WO2012/083151, which claims priority to U.S. Provisional PatentApplication No. 61/424,474, filed Dec. 17, 2010; 61/498,131, filed Jun.17, 2011; 61/497,761, filed Jun. 16, 2011; 61/424,132, filed Dec. 17,2010; 61/498,096, filed Jun. 17, 2011; 61/424,326, filed Dec. 17, 2010;61/498,080, filed Jun. 17, 2011; 61/498,911, filed Jun. 20, 2011, and61/498,943, filed Jun. 20, 2011; U.S. patent application Ser. No.12/970,312, now U.S. Pat. No. 8,460,356, filed Dec. 16, 2010 and Ser.No. 12/970,347, now U.S. Pat. No. 8,603,152, filed Dec. 16, 2010; andPCT Application Nos. PCT/US2010/060764, fUed Dec. 16, 2010 andPCT/US2010/060771, filed Dec. 16, 2010, the disclosure of each of whichis incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention concerns apparatuses and associated methods usefulfor delivering stimulation to the vestibular system and/or the nervoussystem of an individual, thereby inducing physiological changes in theindividual and/or treating a disorder or symptom of the individual.

BACKGROUND

Caloric vestibular stimulation (CVS) has been widely and safely utilizedfor more than a century for diagnostic purposes, particularly in theemergency room to detect brain function after injury and in ear, noseand throat practice to assess balance.

CVS activates the sensory organs of the vestibular system located withinthe inner ear. The core elements consist of the semi-circular canals,which sense rotational motion, and the otoliths, which sense linearacceleration. Motion within the semi-circular canals is detected throughmotion of internal fluid (endolymph), which in turn activates hair cellsthat generate electrical signals, which are then transmitted via the 8thcranial nerve to the brainstem and widely throughout the cerebellum andcortical regions. In traditional CVS, irrigation of the externalauditory canal (the ear canal) with warm or cold water/air changes thedensity of the endolymph in the semi-circular canal of the inner ear,which in turn activates the pathways noted above. Nystagmus, or thevestibulo-ocular reflex, is an easily observed result of CVS, whereinthe eyes move spontaneously, even if the patient is unconscious.

There have been intriguing (but largely anecdotal) reports of using CVSas a therapeutic measure. Survey articles document a variety of outcomesand discuss some of the mechanisms involved (Miller et al., ACTANEUROPSYCHIATRIA 19:183-203 (2007); Been, et al., BRAIN RES. REV.56:346-36 (2007)). Squirting or blowing warm/cold water/air into apatient's ear, however, is crude, does not provide closely controlledthermal activity and is not consistent with medical dosing.Nevertheless, CVS is known to activate specific brainstem, cerebellarand cortical sites, which have therapeutic potential, as demonstratedthrough functional imaging (Bottini et al., EXP. BRAIN. RES. 99:164-169(1994); Bense et al., ANN. N.Y. ACAD. SCI. 1004:440-445 (2003);Dieterich et al., BRAIN 131:2538-2552 (2008); Baier et al., HUM. BRAINMAPPING (Sep. 2, 2009) [e-published ahead of print]; Naito et al., BRAIN126 (2003)).

In addition, vestibular stimulation is also known to release importantneurotransmitters (e.g., serotonin, acetylcholine, histamine,endorphins, vasopressin and dopamine) (Fu-rong et al., CHIN. MED. J.120(2):120-124 (2007); Horii et al., J. NEUROPHYSIOL. 72:605-611 (1994);Tabet, AGE AND AGING 35:336-338 (2006); Horii et al., J. NEUROPHYSIOL.70:1822-1826 (1993); Horii et al., BRAIN RES. 914:179-184 (2001)).

In contrast to both pharmaceutical treatment and neurostimulationdevices which employ electrical signals, CVS appears to have anadvantage: although nystagmus habituates with repetition of CVS (Naitoet al., BRAIN 126 (2003), the vestibular neurological response appearsnot to be patient to such habituation or accommodation. (Emani-Nouri,ACTA OTOLARYNGOLOGICA 76:183-189 (1973)). In addition, CVS does not havethe same potential for side effects like a drug. Yet, CVS has notattained wide-spread use for therapeutic purposes. Hence, there remainsa need for new ways to carry out CVS for therapeutic purposes.

SUMMARY OF THE INVENTION

A first aspect of the present invention is a vestibular stimulationdevice for delivering one or more thermal waveforms to the vestibularsystem and/or the nervous system of a patient. In some embodiments, thevestibular stimulation device comprises, consists essentially of orconsists of an earpiece, a thermoelectric device (TED) and a controller,wherein said TED is thermally coupled to said earpiece and wherein saidcontroller is operatively connected to said TED and is configured toactivate said TED to deliver one or more thermal waveforms to thevestibular system and/or the nervous system of a patient (i.e., toactivate the TED such that the earpiece is warmed and/or cooled so as todeliver the thermal waveform(s) to the vestibular system and/or thenervous system of the patient). In some such embodiments, the vestibularstimulation device further comprises a heat sink, and the TED isthermally coupled between the earpiece and the heat sink such thatactivation of the TED facilitates the transfer or heat between theearpiece and the heat sink. In some embodiments, the controller isconfigured to generate a prescription comprising a set of instructionsfor delivering one or more thermal waveforms to the vestibular systemand/or the nervous system of a patient and to activate the TED todeliver the prescribed thermal waveform(s).

A second aspect of the present invention is a physician control devicefor generating and/or modifying the parameters, indications and/orapprovals of one of more thermal waveforms; for generating, modifying,updating and/or extending one or more prescriptions and/or forreceiving, analyzing and/or transmitting data. In some embodiments, thephysician control device is configured to generate and/or modify theparameters, indications and/or approvals of one or more idealizedthermal waveforms. In some embodiments, the physician control device isconfigured to generate a prescription comprising a set of instructionsfor delivering one or more thermal waveforms to the vestibular systemand/or the nervous system of a patient. In some embodiments, thephysician control device is configured to transmit the parameters,indications and/or approvals of one or more thermal waveforms to one ormore vestibular stimulation devices and/or one or more patient controldevices. In some embodiments, the physician control device is configuredto transmit one or more prescriptions to one or more vestibularstimulation devices and/or one or more patient control devices. In someembodiments, the physician control device is configured to receive datafrom one or more vestibular stimulation devices and/or one or morepatient control devices. In some embodiments, the physician controldevice is configured to transmit data to one or more physician supportdevices.

A third aspect of the present invention is a patient control device forreceiving, analyzing and/or transmitting data. In some embodiments, thepatient control device is configured to receive the parameters,indications and/or approvals of one or more thermal waveforms from aphysician control device. In some embodiments, the patient controldevice is configured to transmit the parameters, indications and/orapprovals of one or more thermal waveforms to one or more vestibularstimulation devices. In some embodiments, the patient control device isconfigured to receive a prescription comprising a set of instructionsfor delivering one or more thermal waveforms to the vestibular systemand/or the nervous system of a patient from a physician control device.In some embodiments, the patient control device is configured totransmit a prescription comprising a set of instructions for deliveringone or more thermal waveforms to the vestibular system and/or thenervous system of a patient to a vestibular stimulation device. In someembodiments, the patient control device is configured to receive datafrom one or more vestibular stimulation devices. In some embodiments,the physician control device is configured to transmit data to one ormore physician control devices.

A fourth aspect of the present invention is a physician support devicefor generating and/or modifying the parameters, indications and/orapprovals of one of more thermal waveforms; for generating, modifying,updating and/or extending one or more prescriptions and/or forreceiving, analyzing and/or transmitting data. In some embodiments, thephysician support device is configured to generate and/or modify theparameters, indications and/or approvals of one or more idealizedthermal waveforms. In some embodiments, the physician support device isconfigured to generate a prescription comprising a set of instructionsfor delivering one or more thermal waveforms to the vestibular systemand/or the nervous system of a patient. In some embodiments, thephysician support device is configured to transmit the parameters,indications and/or approvals of one or more thermal waveforms to one ormore vestibular stimulation devices, one or more patient control devicesand/or one or more physician control devices. In some embodiments, thephysician support device is configured to transmit one or moreprescriptions to one or more vestibular stimulation devices, one or morepatient control devices and/or one or more physician control devices. Insome embodiments, the physician support device is configured to receivedata from one or more vestibular stimulation devices, one or morepatient control devices and/or one or more physician control devices.

A fifth aspect of the present invention is a registry for receiving,storing and/or transmitting data. In some embodiments, the registry isconfigured to receive data associated with the parameters, indicationsand/or approvals of one or more thermal waveforms (e.g., idealizedthermal waveforms) from one or more vestibular stimulation devices, oneor more patient control devices, one or more physician control devicesand/or one or more physician support devices. In some embodiments, theregistry is configured to transmit data associated the parameters,indications and/or approvals of one of more idealized thermal waveformsto one or more vestibular stimulation devices, one or more patientcontrol devices, one or more physician control devices and/or one ormore physician support devices.

A sixth aspect of the present invention is a telemedicine module forfacilitating and/or controlling communications between vestibularstimulation devices, patient control devices, physician control devicesand/or physician support devices. In some embodiments, the telemedicinemodule is configured to facilitate and/or control communications betweena vestibular stimulation device, ad patient control device, a physiciancontrol device and/or a physician support device by ensuring that datais transmitted between the devices in a manner that complies with anyand all applicable laws and/or regulations (e.g., the Health InsurancePortability and Accountability Act of 1996 (P.L. 104-191; “HIPAA”)).

A seventh aspect of the present invention is a vestibular stimulationsystem for delivering one or more thermal waveforms to the vestibularsystem and/or the nervous system of a patient. In some embodiments, thevestibular stimulation system comprises a physician control deviceconfigured to generate a prescription comprising a set of instructionsfor delivering one or more thermal waveforms to the vestibular systemand/or the nervous system of a patient and a vestibular stimulationdevice configured to deliver the prescribed thermal waveforms to thepatient.

An eighth aspect of the present invention is a method of delivering oneor more thermal waveforms to the vestibular system and/or the nervoussystem of a patient. In some embodiments, the method comprisesgenerating a prescription comprising a set of instructions fordelivering one or more thermal waveforms to the vestibular system and/orthe nervous system of a patient and delivering the prescribed thermalwaveform(s) to the patient using a vestibular stimulation device.

A ninth aspect of the present invention is a method of updating awaveform database. In some embodiments, the method comprises analyzingphysician feedback data and modifying one or more thermal waveforms inthe waveform database responsive to analyzing the physician feedbackdata.

The foregoing and other objects and aspects of the present invention areexplained in greater detail in the drawings herein and the specificationset forth below. All patent references cited herein are specificallyintended to be incorporated herein by reference in their entirety.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of a vestibular stimulation device accordingto some embodiments of the present invention.

FIGS. 2-12 are screenshots illustrating various functionalities of acontroller according to some embodiments of the present invention,wherein the controller comprises an interactive touchscreen.

FIG. 2 depicts a startup screen wherein the current time is shown in theupper right-hand corner of the screen.

FIG. 3 depicts a waveform module screen wherein the user has generated athermal waveform by drawing the desired waveform on the interactivetouch screen and wherein the waveform module has identified fourteenwaveform modulation points (gray diamonds).

FIG. 4 depicts a waveform module screen wherein the thermal waveformdepicted in FIG. 3 has been modified by selecting the third waveformmodulation point of the thermal waveform and moving it to a highertemperature.

FIG. 5 depicts a treatment module screen that enables a user to provideinstructions as to how many days are to be in a treatment schedule andhow many treatments may be administered per day.

FIG. 6 depicts a treatment module screen that enables a user toauthorize delivery of one or more prescribed thermal waveform(s) duringone or more specified time periods by touching an available treatmentwindow (represented by a grey rectangle with a black dash in its center)and then providing instructions as to which thermal waveform(s) is/areto be delivered during that treatment window (as shown in FIGS. 7-8) andinstructions as to when the treatment window is to begin and end (asshown in FIG. 9).

FIG. 7 depicts a treatment module screen that enables a user to provideinstructions to apply an idealized thermal waveform to the ear canal ofa patient by touching the circular selection indicator to the right ofthe desired waveform.

FIG. 8 depicts a treatment module screen that enables a user to provideinstructions to apply the selected thermal waveform to the left or rightear canal of a patient by touching the upper or lower graph,respectively.

FIG. 9 depicts a treatment module screen that enables a user to provideinstructions as to when a given treatment window is to begin and end(i.e., to provide instructions as to the window of time in which one ormore prescribed thermal waveforms may be administered to a patient).

FIG. 10 depicts a treatment module screen that enables a user to modifya treatment schedule by editing and/or copying previously establishedtreatment sessions (e.g., by changing which thermal waveform(s) are tobe delivered during a given treatment session (as shown in FIGS. 7-8),by changing the start and/or end time for one or more treatment sessions(as shown in FIG. 9), by deleting one or more treatment sessions, etc.).

FIG. 11 depicts a control module screen wherein a thermal waveformdelivered to the left ear canal and a thermal waveform being deliveredto the right ear canal of a patient are graphically represented, withthe current progress of each waveform represented by the changing of thedepicted waveform from light gray to dark grey (i.e., the elapsed timeis represented by the dark gray portion of each waveform and the timeremaining is represented by the light gray portion of each waveform),and wherein the user may stop the treatment session by touching the “X”in the lower left-hand corner of the screen.

FIG. 12 depicts a password protection screen.

FIG. 13 is a block diagram of a controller according to some embodimentsof the present invention.

FIG. 14 is a block diagram of a controller according to some embodimentsof the present invention.

FIG. 15 is a block diagram of a controller according to some embodimentsof the present invention.

FIG. 16 is an illustration of a controller according to some embodimentsof the present invention.

FIG. 17 is an illustration of a controller according to some embodimentsof the present invention.

FIG. 18A is a perspective view of an earpiece according to someembodiments of the present invention.

FIG. 18B is a side view of an earpiece according to some embodiments ofthe present invention.

FIG. 18C is a cross-sectional view of an earpiece according to someembodiments of the present invention.

FIG. 19 is a perspective view of a vestibular stimulation deviceaccording to some embodiments of the present invention.

FIG. 20 is an exploded view of a vestibular stimulation device headsethousing according to some embodiments of the present invention.

FIG. 21A is an exploded, perspective view of an earpiece, a TED and aheat sink according to some embodiments of the present invention.

FIG. 21B is an exploded, cross-sectional view of an earpiece, a TED, aspacer and a heat sink according to some embodiments of the presentinvention.

FIG. 22 is a block diagram of a physician control device according tosome embodiments of the present invention.

FIG. 23 is a block diagram of a physician control device according tosome embodiments of the present invention.

FIG. 24 is a block diagram of a physician control device according tosome embodiments of the present invention.

FIG. 25 is a block diagram of a patient control device according to someembodiments of the present invention.

FIG. 26 is a block diagram of a patient control device according to someembodiments of the present invention.

FIG. 27 is a block diagram of a patient control device according to someembodiments of the present invention.

FIG. 28 is a block diagram of a physician support device according tosome embodiments of the present invention.

FIG. 29 is a block diagram of a physician support device according tosome embodiments of the present invention.

FIG. 30 is a block diagram of a physician support device according tosome embodiments of the present invention.

FIG. 31 is a block diagram of a registry according to some embodimentsof the present invention.

FIG. 32 is a block diagram of a registry according to some embodimentsof the present invention.

FIG. 33 is a block diagram of a vestibular stimulation system accordingto some embodiments of the present invention comprising a vestibularstimulation device and a physician control device.

FIG. 34 is a block diagram of a vestibular stimulation system accordingto some embodiments of the present invention comprising a physiciancontrol device and a plurality of vestibular stimulation devices.

FIG. 35 is a block diagram of a vestibular stimulation system accordingto some embodiments of the present invention comprising a vestibularstimulation device and a physician control device.

FIG. 36 is a block diagram of a vestibular stimulation system accordingto some embodiments of the present invention comprising a vestibularstimulation device, a patient control device and a physician controldevice.

FIG. 37 is a block diagram of a vestibular stimulation system accordingto some embodiments of the present invention comprising a physiciancontrol device, a plurality of patient control devices and a pluralityof vestibular stimulation devices.

FIG. 38 is a block diagram of a vestibular stimulation system accordingto some embodiments of the present invention comprising a vestibularstimulation device, a patient control device and a physician controldevice.

FIG. 39 is a block diagram of a vestibular stimulation system accordingto some embodiments of the present invention comprising a vestibularstimulation device, a physician control device and a physician supportdevice.

FIG. 40 is a block diagram of a vestibular stimulation system accordingto some embodiments of the present invention comprising a physiciansupport device, a plurality of physician control devices and a pluralityof vestibular stimulation devices.

FIG. 41 is a block diagram of a vestibular stimulation system accordingto some embodiments of the present invention comprising a vestibularstimulation device, a physician control device and a physician supportdevice.

FIG. 42 is a block diagram of a vestibular stimulation system accordingto some embodiments of the present invention comprising a vestibularstimulation device, a physician control device, a physician supportdevice and a registry.

FIG. 43 is a block diagram of a vestibular stimulation system accordingto some embodiments of the present invention comprising a registry, aplurality of physician control devices and a plurality of vestibularstimulation devices.

FIG. 44 is a block diagram of a vestibular stimulation system accordingto some embodiments of the present invention comprising a vestibularstimulation device, a physician control device and a registry.

FIG. 45 is a block diagram illustrating a method of delivering one ormore thermal waveforms to the vestibular system and/or the nervoussystem of a patient according to some embodiments of the presentinvention.

FIG. 46 is a block diagram illustrating a method of delivering one ormore thermal waveforms to the vestibular system and/or the nervoussystem of a patient according to some embodiments of the presentinvention.

FIGS. 47A-47F are schematic diagrams of various non-limiting examples ofthermal waveforms that may be delivered using the devices, systems andmethods of the present invention. While each line A through Fillustrates several cycles of a given frequency and waveform shape, notethat “waveform” herein generally refers to a single cycle of a givenfrequency and waveform shape.

DETAILED DESCRIPTION

The present invention is explained in greater detail below. Thisdescription is not intended to be a detailed catalog of all thedifferent ways in which the invention may be implemented or of all thefeatures that may be added to the instant invention. For example,features illustrated with respect to one embodiment may be incorporatedinto other embodiments, and features illustrated with respect to aparticular embodiment may be deleted from that embodiment. In addition,numerous variations and additions to the various embodiments suggestedherein, which do not depart from the instant invention, will be apparentto those skilled in the art in light of the instant disclosure. Hence,the following specification is intended to illustrate some particularembodiments of the invention, and not to exhaustively specify allpermutations, combinations and variations thereof.

It will be understood that when an element or layer is referred to asbeing “on”, “attached to”, “connected to”, “coupled to”, “coupled with”or “contacting” another element or layer, it can be directly on,connected or coupled to the other element or layer or interveningelements or layers may be present. In contrast, when an element isreferred to as being “directly on,” “directly connected to” or “directlycoupled to” another element or layer, there are no intervening elementsor layers present. It will also be appreciated by those of skill in theart that references to a structure or feature that is disposed“adjacent” another structure or feature may have portions that overlapor underlie the adjacent structure or feature.

The present invention is described below with reference to blockdiagrams and/or flowchart illustrations of methods, systems and/orcomputer program products according to embodiments of the invention.

It is understood that various blocks of the block diagrams and/orflowchart illustrations, and combinations of blocks in the blockdiagrams and/or flowchart illustrations, can be implemented by computerprogram instructions. These computer program instructions may beprovided to a processor of a general purpose computer, special purposecomputer and/or other programmable data processing apparatus to producea machine, such that the instructions, which execute via the processorof the computer or other programmable data processing apparatus, createmeans for implementing the functions/acts specified in the blockdiagrams and/or flowchart illustrations. The computer programinstructions may also be stored in a computer-readable memory that candirect a computer or other programmable data processing apparatus tofunction in a particular manner, such that the instructions stored inthe computer-readable memory produce an article of manufacture includinginstructions which implement the function/act specified in the blockdiagram and/or flowchart illustrations. The computer programinstructions may also be loaded onto a computer or other programmabledata processing apparatus to cause a series of operational steps to beperformed on the computer or other programmable data processingapparatus to produce a computer-implemented process such that theinstructions which execute on the computer or other programmable dataprocessing apparatus provide steps for implementing the functions/actsspecified in the block diagrams and/or flowchart illustrations.

Accordingly, the present invention may be embodied in hardware and/orsoftware (including firmware, resident software, micro-code, etc.).Furthermore, embodiments of the present invention may take the form of acomputer program product on a computer-usable or computer-readablenon-transient storage medium having computer-usable or computer-readableprogram code embodied in the medium for use by or in connection with aninstruction execution system. In the context of this document, acomputer usable or computer-readable non-transient storage medium may beany medium that can contain and/or store the program for use by or inconnection with the instruction execution system, apparatus or device.For example, the computer-usable or computer-readable medium may be anelectronic, optical, electromagnetic, infrared or semiconductor system,apparatus or device.

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which this invention belongs. It will befurther understood that terms, such as those defined in commonly useddictionaries, should be interpreted as having a meaning that isconsistent with their meaning in the context of the specification andrelevant art and should not be interpreted in an idealized or overlyformal sense unless expressly so defined herein. Well-known functions orconstructions may not be described in detail for brevity and/or clarity.

As used herein, the terms “actively controlled waveform” and “activelycontrolled, time-varying thermal waveform” refer to a thermal waveformin which the intensity and/or the directionality of the activationsignal used to deliver the thermal waveform and/or the temperature ofthe earpiece used to deliver the thermal waveform is repeatedly adjusted(e.g., continuously adjusted or substantially continuously adjusted)during delivery of the thermal waveform. For example, the activationsignal driving the TED(s) used to deliver the thermal waveform may becontinuously adjusted in response to feedback data from one or moresensors (e.g., a temperature sensor configured to sense the temperatureof the earpiece with which the TED(s) is/are associated). Such activecontrol may be used to minimize errors in the delivery of a prescribedthermal waveform (e.g., by minimizing thermal drift, which may otherwiseallow the patient's body temperature to adversely affect the accuracy).

As used herein, the term “adjuvant treatment” refers to a treatmentsession in which the delivery of one or more thermal waveforms to thevestibular system and/or the nervous system of a patient modifies theeffect(s) of one or more active agents and/or therapies. For example,the delivery of one or more thermal waveforms to the vestibular systemand/or the nervous system of a patient may enhance the effectiveness ofa pharmaceutical agent (by restoring the therapeutic efficacy of a drugto which the patient had previously become habituated, for example).Likewise, the delivery of one or more thermal waveforms to thevestibular system and/or the nervous system of a patient may enhance theeffectiveness of counseling or psychotherapy. In some embodiments,delivery of one or more thermal waveforms to the vestibular systemand/or the nervous system of a patient may reduce or eliminate the needfor one or more active agents and/or therapies. Adjuvant treatments maybe effectuated by delivering one or more thermal waveforms to thevestibular system and/or the nervous system of a patient prior to,currently with and/or after administration of one or more active agentsand/or therapies.

As used herein, the term “and/or” includes any and all combinations ofone or more of the associated listed items.

As used herein, the terms “chronic treatment,” “chronically treating”and the like refer to a therapeutic treatment carried out at least onceper week (e.g., two or three times per week, daily, etc.) over anextended period of time. Chronic treatment typically lasts at least oneto two weeks (and, in some embodiments, at least one to two months), butmay last as long as required to achieve and/or maintain therapeuticefficacy for the particular condition or disorder for which thetreatment is carried out (i.e., the device may be used periodicallythroughout the patient's life).

As used herein, the term “controller feedback data” refers to data thatis transmitted to the controller by one or more TEDs and/or one or moresensors and is used by the controller to verify the accuracy of thethermal waveform(s) being delivered, to modulate the activation of oneor more TEDs so as to deliver the appropriate thermal waveform(s) and/orto enable the controller to activate safety precautions in the event ofa system failure. For example, controller feedback data may comprisedata associated with the temperature of an earpiece, wherein said datais used to verify that the appropriate temperature is being delivered tothe ear canal of a patient, to enable the controller toincrease/decrease the activation of one or more TEDs to ensure that theappropriate temperature is delivered to the ear canal of a patientand/or to trigger a system shutdown if the temperature of the earpiecedrops below a low temperature threshold (e.g., about 10 degreesCentigrade) or exceeds a high temperature threshold (e.g., about 50degrees Centigrade). Likewise, controller feedback data may comprisedata associated with the temperature of a heat sink that is thermallycoupled to one or more TEDs, wherein said data is used to trigger asystem shutdown if the temperature of the heat sink exceeds a hightemperature threshold (e.g., about 50 degrees Centigrade).

As used herein, the term “data associated with the delivery of one ormore thermal waveforms” refers to information associated with thedelivery of one or more thermal waveforms and may include, but is notlimited to, data associated with the target time/temperature parametersof the thermal waveform(s), the time/temperature parameters of thethermal waveform(s) delivered; the date/time of delivery of the thermalwaveform(s), the temperature of the patient's ear canal(s) at varioustime points before, during and/or after delivery of the thermalwaveform(s); the temperature of the patient's inner ear(s) at varioustime points before, during and/or after delivery of the thermalwaveform(s); the fit of the earpiece(s) at various time points before,during and/or after delivery of the thermal waveform(s); an estimate ofthe thermal contact between the earpiece(s) and the patient's earcanal(s) at various time points before, during and/or after delivery ofthe thermal waveform(s); patient-specific time constants (e.g., a timeconstant associated with the transduction of heat from the ear canal tothe inner ear); reaction time (i.e., how long it took for the patient toreact to the thermal waveform(s)); effectiveness of the thermalwaveform(s) (e.g., whether and to what extent symptoms were relieved,whether the thermal waveform(s) enhanced the effectiveness of anotheragent/therapy, etc.); stability of the treatment (i.e., how long theeffects of the treatment lasted); instability of the treatment (i.e.,which condition(s) and/or symptom(s) returned and when did it/theyreturn); the presence or absence of comorbid disorders, injuries and/ordiseases; disorder, injury and/or disease modulation(s) and/or othermodification(s) that occurred as a result of treatment; the cognitiveeffect(s) of one or more thermal waveforms; patient compliance (e.g.,whether the patient initiated delivery at the prescribed time, whetherthe patient completed the prescribed treatment session, whether theearpiece(s) remained properly fitted in the patient's ear canal(s) forthe duration of the treatment session, etc.); the mood of the patientbefore, during and/or after his/her treatment session(s) (e.g.,videos/images of a patient that may be used to assess mood); objectivesmeasures of efficacy (e.g., nystamography data, EEG data, MRI data,heart rate data, blood pressure data); subjective measures of efficacy(e.g., a patient-reported pain score); blood chemistry data (e.g., bloodA1c levels, blood glucose levels and blood cortisol levels); salivachemistry data (e.g., saliva cortisol levels); urine chemistry data(e.g., urine cortisol levels)) and comments the patient made abouthis/her treatment session(s) (e.g., comments made to a physician,submitted in response to an automated survey and/or recorded in atreatment diary). In some embodiments, data associated with the deliveryof one or more thermal waveforms comprises controller feedback data,patient feedback data and/or physician feedback data. In someembodiments, data associated with the delivery of one or more thermalwaveforms comprises, consists essentially of or consists of dataassociated with the precise time/temperature parameters of the thermalwaveform(s) delivered to the patient and a subjective measure ofefficacy (e.g., a patient-reported pain score).

As used herein, the term “data associated with the fit of theearpiece(s)” may include, but is not limited to, data associated withthe impedance between an earpiece inserted into the ear canal of apatient and an electrode affixed to a second location on/in saidpatient's body (e.g., an electrode placed in or adjacent to thepatient's other ear canal), data associated with the rate at which theear canal and/or the inner ear cooled in response to a cooling stimulus(e.g., data from a temperature sensor, such as thermistor, that monitorshow quickly the ear canal and/or the inner ear cools in response to acooling waveform), data associated with the rate at which the ear canaland/or the inner ear warmed in response to a warming stimulus (e.g.,data from a temperature sensor, such as a thermistor, that monitors howquickly the ear canal and/or the inner ear warms in response to awarming waveform) and patient comments regarding the subjective fit ofthe earpiece(s). In some embodiments, data associated with the fit ofthe earpiece(s) comprises, consists essentially or consists of dataassociated with the impedance between an earpiece inserted into theright ear canal of a patient and an earpiece inserted into the left earcanal of said patient.

As used herein, the terms “idealized thermal waveform” and “idealizedwaveform” refer to a thermal waveform that has been indicated and/orapproved for use in the treatment of one or morediseases/disorders/injuries and/or for use in the provision ofneuroprotection, enhanced cognition and/or increased cognitive reserve.For example, a thermal waveform may be indicated for use in thetreatment of migraines if it has effectively treated migraines in thepast or if it belongs to a class of thermal waveforms that are known totreat migraines. Likewise, a thermal waveform may be approved for use inthe treatment of a given disorder if it has received regulatory approval(e.g. FDA approval) for such use, or if it belongs to a class of thermalwaveforms that have been approved for the treatment of that disorder. Anidealized thermal waveform may be indicated/approved for use in thetreatment of multiple diseases/disorders/injuries.

As used herein, the term “patient” refers to both human subjects andanimal subjects, including, but not limited to, mice, rats, rabbits,cats, dogs, pigs, horses, monkeys, apes, etc. The patient may be male orfemale. That patient may be of any suitable age, including infant,juvenile, adolescent, adult and geriatric ages. In some embodiments, themethods, devices and systems of the present invention may be used toinduce physiological and/or psychological responses in a patient formedically diagnostic and/or therapeutic purposes. For example, themethods, devices and systems of the present invention may be used todiagnose and/or treat mammalian subjects, such as mice, rats, pigs andmonkeys, for medical research or veterinary purposes.

As used herein, the term “patient information” refers to data associatedwith one or more patients. Patient information may comprise, but is notlimited to, information related, to a patient's identity, a patient'scognitive abilities, a patient's medical history, a patient's currentsymptoms (if any), a patient's present diagnosis (if any), a patient'scurrent prescriptions (if any) and data associated with the delivery ofone or more thermal waveforms to the vestibular system and/or thenervous system of a patient.

As used herein, the term “patient feedback data” refers to dataassociated with patient feedback regarding the delivery of one or morethermal waveforms. Patient feedback data may comprise, but is notlimited to, a patient's evaluation of their pain level before, duringand/or after delivery of the thermal waveform(s) (e.g., patient-reportedpain scores given before, during and after a treatment session) andpatient comments (e.g., comments regarding a patient's opinion as to theefficacy of a given waveform or the effect(s) of certain waveformmodifications, etc.).

As used herein, the term “physician feedback data” refers to dataassociated with physician feedback regarding the delivery of one or morethermal waveforms. Physician feedback data may comprise, but is notlimited to, patient information from the patient history database of oneor more physician control devices and comments from one or morephysicians (e.g., comments regarding a physician's opinion as to theefficacy of a given waveform or the effect(s) of certain waveformmodifications, etc.).

As used herein, the terms “prescription” and “prescription protocol”refer to a set of instructions and/or limitations associated withstimulation of the vestibular system and/or the nervous system of apatient. In some embodiments, a prescription comprises, consistsessentially of or consists of a set of instructions for delivering ofone or more thermal waveforms (e.g., one or more actively controlled,time-varying thermal waveforms) to the vestibular system and/or thenervous system of a patient (e.g., by warming and/or cooling an earpiecepositioned in the ear canal of the patient). A prescription may comprisea set of instructions for delivering one or more thermal waveforms tothe left vestibular system of a patient (by delivering one or morethermal waveforms to the left ear canal of the patient) and/or a set ofinstructions for delivering one or more thermal waveforms to the rightvestibular system of a patient (by delivering one or more thermalwaveforms to the left ear canal of the patient) (i.e., one prescriptionmay comprise instructions for stimulating both the right and leftvestibular systems). A prescription may comprise any suitableinstructions and/or limitations, including, but not limited to, theparameters of the waveform(s) to be delivered to the patient, the numberand frequency of treatment sessions (e.g., X treatment sessions over Ytime period), a limitation as to how many treatment sessions may beadministered during a given time period (e.g., no more than X treatmentsessions within Y time period), instructions as to which thermalwaveform(s) will be administered during a given treatment session (andin what order they are to be administered), instructions as to whichvestibular system will receive a given waveform (e.g., right, left orboth) and an expiration date. In some embodiments, a prescriptioncomprises instructions for delivering a placebo (i.e., for fooling apatient into believing one or more thermal waveforms has been deliveredeven though no such deliver has occurred). In some embodiments, theprescription is generated by a physician. Any conventional securitymeans may be provided to prevent unauthorized modification of theprescription (e.g., the prescription may be password protected, withonly the prescribing physician having knowledge of and/or access to thepassword).

As used herein, the terms “treatment,” “treat,” and “treating” refer toreversing, alleviating, reducing the severity of, delaying the onset of,inhibiting the progress of or preventing a disease or disorder asdescribed herein, or at least one symptom of a disease or disorder asdescribed herein (e.g., treating one or more of tremors, bradykinesia,rigidity or postural instability associated with Parkinson's disease;treating one or more of intrusive symptoms (e.g., dissociative states,flashbacks, intrusive emotions, intrusive memories, nightmares, andnight terrors), avoidant symptoms (e.g., avoiding emotions, avoidingrelationships, avoiding responsibility for others, avoiding situationsreminiscent of the traumatic event) or hyperarousal symptoms (e.g.,exaggerated startle reaction, explosive outbursts, extreme vigilance,irritability, panic symptoms, sleep disturbance) associated withpost-traumatic stress disorder). In some embodiments, treatment may beadministered after one or more symptoms have developed. In otherembodiments, treatment may be administered in the absence of symptoms.For example, treatment may be administered to a susceptible individualprior to the onset of symptoms (e.g., in light of a history of symptomsand/or in light of genetic or other susceptibility factors). Treatmentmay also be continued after symptoms have resolved—for example, toprevent or delay their recurrence. Treatment may comprise providingneuroprotection, enhancing cognition and/or increasing cognitivereserve. Treatment may be as an adjuvant treatment as further describedherein.

The present invention may be used to treat a patient for any reason. Insome embodiments, the present invention is used to treat one or moredisorders. Disorders for which treatment may be carried out include, butare not limited to, headaches, depression, anxiety (e.g., as experiencedin post-traumatic stress disorder (“PTSD”) or other anxiety disorders),dementia, spatial neglect, Parkinson's disease, seizures (e.g.,epileptic seizures) and diabetes (e.g., type II diabetes).

Additional disorders and conditions that can be treated by the methodsand systems of the present invention include, but are not limited to,tinnitus, neuropathic pain (e.g., migraine headaches), brain injury(acute brain injury, excitotoxic brain injury, traumatic brain injury,etc.), spinal cord injury, body image or integrity disorders (e.g.,spatial neglect), visual intrusive imagery, neuropsychiatric disorders(e.g., depression), bipolar disorder, neurodegenerative disorders (e.g.,Parkinson's disease), asthma, dementia, insomnia, stroke, cellularischemia, metabolic disorders, (e.g., diabetes), PTSD, addictivedisorders, sensory disorders, motor disorders, and cognitive disorders.

Headaches that may be treated by the methods and apparatuses of thepresent invention include, but are not limited to, primary headaches(e.g., migraine headaches, tension-type headaches, trigeminal autonomiccephalagias and other primary headaches, such as cough headaches andexertional headaches) and secondary headaches. See, e.g., InternationalHeadache Society Classification ICHD-II.

Migraine headaches that may be treated by the methods and apparatuses ofthe present invention may be acute/episodic/chronic andunilateral/bilateral. The migraine headache may be of any type,including, but not limited to, migraine with aura, migraine withoutaura, hemiplegic migraine, opthalmoplegic migraine, retinal migraine,basilar artery migraine, abdominal migraine, vestibular migraine andprobable migraine. As used herein, the term “vesibular migraine” refersto migraine with associated vestibular symptoms, including, but notlimited to, head motion intolerance, unsteadiness, dizziness andvertigo. Vestibular migraine includes, but is not limited to, thoseconditions sometimes referred to as vertigo with migraine,migraine-associated dizziness, migraine-related vestibulopathy,migrainous vertigo and migraine-related vertigo. See, e.g., Teggi etal., HEADACHE 49:435-444 (2009).

Tension-type headaches that may be treated by the methods andapparatuses of the present invention, include, but are not limited to,infrequent episodic tension-type headaches, frequent episodictension-type headaches, chronic tension-type headache and probabletension-type headache.

Trigeminal autonomic cephalagias that may be treated by the methods andapparatuses of the present invention, include, but are not limited to,cluster headaches, paroxysmal hemicranias, short-lasting unilateralneuralgiform headache attacks with conjunctival injection and tearingand probable trigeminal autonomic cephalagias. Cluster headache,sometimes referred to as “suicide headache,” is considered differentfrom migraine headache. Cluster headache is a neurological disease thatinvolves, as its most prominent feature, an immense degree of pain.“Cluster” refers to the tendency of these headaches to occurperiodically, with active periods interrupted by spontaneous remissions.The cause of the disease is currently unknown. Cluster headaches affectapproximately 0.1% of the population, and men are more commonly affectedthan women (in contrast to migraine headache, where women are morecommonly affected than men).

Other primary headaches that may be treated by the methods andapparatuses of the present invention, include, but are not limited to,primary cough headache, primary exertional headache, primary headacheassociated with sexual activity, hypnic headache, primary thunderclapheadache, hemicranias continua and new daily-persistent headache.Sensory disorders that may be treated by the methods and apparatuses ofthe present invention include, but are not limited to, vertigo,dizziness, seasickness, travel sickness cybersickness, sensoryprocessing disorder, hyperacusis, fibromyalgia, neuropathic pain(including, but not limited to, complex regional pain syndrome, phantomlimb pain, thalamic pain syndrome, craniofacial pain, cranialneuropathy, autonomic neuropathy, and peripheral neuropathy (including,but not limited to, entrapment-, heredity-, acute inflammatory-,diabetes-, alcoholism-, industrial toxin-, Leprosy-, Epstein BarrVirus-, liver disease-, ischemia-, and drug-induced neuropathy)),numbness, hemianesthesia, and nerve/root plexus disorders (including,but not limited to, traumatic radiculopathies, neoplasticradiculopathies, vaculitis, and radiation plexopathy).

Motor disorders that may be treated by the method and apparatuses of thepresent invention include, but are not limited to, upper motor neurondisorders such as spastic paraplegia, lower motor neuron disorders suchas spinal muscular atrophy and bulbar palsy, combined upper and lowermotor neuron syndromes such as familial amyotrophic lateral sclerosisand primary lateral sclerosis, and movement disorders (including, butnot limited to, Parkinson's disease, tremor, dystonia, TouretteSyndrome, myoclonus, chorea, nystagmus, spasticity, agraphia,dysgraphia, alien limb syndrome, and drug-induced movement disorders).

Cognitive disorders that may be treated by the method and apparatuses ofthe present invention include, but are not limited to, schizophrenia,addiction, anxiety disorders, depression, bipolar disorder, dementia,insomnia, narcolepsy, autism, Alzheimer's disease, anomia, aphasia,dysphasia, parosmia, spatial neglect, attention deficit hyperactivitydisorder, obsessive compulsive disorder, eating disorders, body imagedisorders, body integrity disorders, post-traumatic stress disorder,intrusive imagery disorders, and mutism.

Metabolic disorders that may be treated by the present invention includediabetes (particularly type II diabetes), hypertension, obesity, etc.

Addiction, addictive disorders, or addictive behavior that may betreated by the present invention includes, but is not limited to,alcohol addiction, tobacco or nicotine addiction (e.g., using thepresent invention as a smoking cessation aid), drug addictions (e.g.,opiates, oxycontin, amphetamines, etc.), food addictions (compulsiveeating disorders), etc.

In some embodiments, the patient has two or more of the aboveconditions, and both conditions are treated concurrently with themethods and systems of the invention. For example, a patient with bothdepression and anxiety (e.g., PTSD) can be treated for both disorders,concurrently, with the methods and systems of the present invention.

As used herein, the term “vestibular system” has the meaning ascribed toit in the medical arts and includes, but is not limited to, thoseportions of the inner ear known as the vestibular apparatus and thevestibulocochlear nerve. The vestibular system, therefore, furtherincludes, but is not limited to, those parts of the brain that processsignals from the vestibulocochlear nerve.

As used herein, the terms “waveform,” “waveform stimulus” and “thermalwaveform” refer to a thermal stimulus (heating and/or cooling) deliveredto the ear canal of a patient. “Waveform” is not to be confused with“frequency,” the latter term concerning the rate of delivery of aparticular waveform. The term “waveform” is used herein to refer to onecomplete cycle thereof, unless additional cycles (of the same, ordifferent, waveform) are indicated. As discussed further below,time-varying thermal waveforms are preferred over square waveforms incarrying out the present invention.

In general, a waveform of the present invention comprises a leadingedge, a peak, and a trailing edge.

The waveform leading edge is preferably ramped or time-varying: that is,the amplitude of the waveform increases through a plurality of differenttemperature points over time (e.g., at least 5, 10, or 15 or moredistinct temperature points, and in some embodiments at least 50, 100,or 150 or more distinct temperature points, from start to peak). Theshape of the leading edge may be a linear ramp, a curved ramp (e.g.,convex or concave; logarithmic or exponential), or a combinationthereof. A vertical cut may be included in the waveform leading edge, solong as the remaining portion of the leading edge progresses through aplurality of different temperature points over time as noted above.

The peak of the waveform represents the amplitude of the waveform ascompared to the patient's body temperature. In general, an amplitude ofat least 5 or 7 degrees Centigrade is preferred for both heating andcooling waveform stimulation. In general, an amplitude of up to 25degrees Centigrade is preferred for cooling waveform stimulation (e.g.,15 degrees Centigrade). In general, an amplitude of up to 8 or 10degrees Centigrade is preferred for heating waveform stimulus (e.g., 6degrees Centigrade). The peak of the waveform may be truncated (that is,the waveform may reach an extended temperature plateau), as long as thedesired characteristics of the leading edge, and preferably trailingedge, are retained. For heating waveforms, truncated peaks of longduration (that is, maximum heat for a long duration) are less preferred,particularly at higher heats, because of the potential that the patientmay experience a burning sensation.

The waveform trailing edge is preferably ramped or time-varying: thatis, the amplitude of the waveform decreases through a plurality ofdifferent temperature points over time (e.g., at least 5, 10, or 15 ormore distinct temperature points, or in some embodiments at least 50,100, or 150 or more distinct temperature points, from peak to trough).The shape of the trailing edge may be a linear ramp, a curved ramp(e.g., convex or concave; logarithmic or exponential), or a combinationthereof. A vertical cut may again be included in the waveform trailingedge, as long as the remaining portion of the trailing edge progressesthrough a plurality of different temperature points over time as notedabove.

The duration of a waveform (or the frequency of that waveform stimulus)is the time from the onset of the leading edge to either the conclusionof the trailing edge or (in the case of a vertically cut waveform) theonset of a subsequent waveform. In general, each waveform has aduration, or frequency, of from one or two minutes up to ten or twentyminutes.

If a first waveform is followed by a second waveform, the minimalstimulus point therebetween (i.e., the point of minimal heating orminimal cooling) is referred to as a trough. Like a peak, the trough maybe truncated, as long as the desired characteristics of the trailingedge and the following leading edge are retained. While the trough mayrepresent a return to the patient's current body temperature, in someembodiments minor thermal stimulation (e.g., cooling or heating by 1 or2 degrees up to 4 or 5 degrees Centigrade) may continue to be applied atthe trough (or through a truncated trough).

In a treatment session, a plurality of waveforms may be delivered insequence. In general, a treatment session will comprise 1, 2 or 3waveforms, up to about 10 or 20 or more waveforms deliveredsequentially. Each individual waveform may be the same, or different,from the other waveform(s).

The first waveform of a treatment session is initiated at a start point,which start point may be at or about the patient's body temperature atthe time the treatment session is initiated (typically a range of about34 to 38 degrees Centigrade, around a normal body temperature of about37 degrees Centigrade. The lower point, 34, is due to the coolness ofthe ear canal in comparison with the rest of the body. It typically willnot be above about 37 unless the patient is febrile). Note that, whilethe patient's ear canal may be slightly less than body temperature(e.g., about 34 to 36 degrees Centigrade), the starting temperature forthe waveform is typically body temperature (the temperature of the innerear), or about 37 degrees Centigrade. In some embodiments, however, thetemperature of the treatment device may not have equilibrated with theear canal prior to the start of the treatment session, and in such casethe start point for at least the first waveform may be at a value closerto room temperature (normally bout 23 to 26 degrees Centigrade).

A treatment session may have a total duration of five or ten minutes, upto 20 or 40 minutes or more, depending on factors such as the specificwaveform or waveforms delivered, the patient, the condition beingtreated, the benefit being sought, etc. In some embodiments, a treatmentsession may comprise one or more breaks (i.e., periods wherein no CVS isgiven). For example, a treatment session may comprise multiplestimulation periods with a break between each stimulation period and mayhave a total duration of 60 minutes or more.

Treatment sessions are preferably once a day, though in some embodimentsmore frequent treatment sessions (e.g., two or three times a day ormore) may be employed. Day-to-day treatments may be by any suitableschedule: every day, every other day, twice a week, as needed by thepatient, etc. The overall pattern of treatment is thus typically chronic(in contrast to “acute,” as used in one-time experimental studies).

Vestibular Stimulation Device

As noted above, the present invention provides a vestibular stimulationdevice for delivering one or more thermal waveforms to the vestibularsystem and/or the nervous system of a patient. The vestibularstimulation device may be configured to deliver any suitable thermalwaveform or combination of thermal waveforms, including, but not limitedto, those described in U.S. Provisional Patent Application Nos.61/424,132, 61/498,096, 61/424,326, 61/498,080, 61/498,911 and61/498,943, the disclosure of each of which is incorporated herein byreference in its entirety. In some embodiments, the vestibularstimulation device is configured to deliver one or more activelycontrolled, time-varying thermal waveforms to the vestibular systemand/or the nervous system of a patient.

In some embodiments, the vestibular stimulation device is configured togenerate a prescription comprising a set of instructions for deliveringone or more thermal waveforms to the vestibular system and/or thenervous system of a patient and to deliver the prescribed thermalwaveform(s) to the vestibular system and/or the nervous system of saidpatient.

In some embodiments, the vestibular stimulation device comprises,consists essentially of or consists of an earpiece, a TED and acontroller, wherein said TED is thermally coupled to said earpiece andwherein said controller is operatively connected to said TED. Thecontroller may be configured to activate said TED to deliver one or morethermal waveforms to the vestibular system and/or the nervous system ofa patient (i.e., to activate the TED such that the earpiece is warmedand/or cooled so as to deliver the thermal waveform(s) to the vestibularsystem and/or the nervous system of the patient). In some embodiments,the controller is configured to generate a prescription comprising a setof instructions for delivering one or more thermal waveforms to thevestibular system and/or the nervous system of a patient and to activatethe TED to deliver the prescribed thermal waveform(s).

In some embodiments, the vestibular stimulation device comprises,consists essentially of or consists of an earpiece, a plurality of TEDsand a controller, wherein each of said plurality of TEDs is thermallycoupled to said earpiece and wherein said controller is operativelyconnected to each of said plurality of TEDs. The controller may beconfigured to selectively and separately activate each of said pluralityof TEDs to deliver one or more thermal waveforms to the vestibularsystem and/or the nervous system of a patient (i.e., to activate one ormore of the TEDs such that the earpiece is warmed and/or cooled so as todeliver the thermal waveform(s) to the vestibular system and/or thenervous system of the patient). In some embodiments, the controller isconfigured to generate a prescription comprising a set of instructionsfor delivering one or more thermal waveforms to the vestibular systemand/or the nervous system of a patient and to activate the TEDs todeliver the prescribed thermal waveform(s).

In some embodiments, the vestibular stimulation device comprises,consists essentially of or consists of a pair of earpieces, a pair ofTEDs and a controller, wherein one earpiece is configured so as to beinsertable into the left ear canal of a patient and the other earpieceis configured so as to be insertable into the right canal of thepatient, wherein one TED is thermally coupled to each earpiece andwherein said controller is operatively connected to each TED. Thecontroller may be configured to selectively and separately activate eachof said TEDs to deliver one or more thermal waveforms to the vestibularsystem and/or the nervous system of the patient. In some embodiments,the controller is configured to generate a prescription comprising a setof instructions for delivering one or more thermal waveforms to thevestibular system and/or the nervous system of the patient and toactivate the TEDs to deliver the prescribed thermal waveform(s).

In some embodiments, the vestibular stimulation device comprises,consists essentially of or consists of a pair of earpieces, a pluralityof TEDs and a controller, wherein one earpiece is configured so as to beinsertable into the left ear canal of a patient and the other earpieceis configured so as to be insertable into the right canal of thepatient, wherein at least one of said plurality of TEDs is thermallycoupled to each earpiece and wherein said controller is operativelyconnected to each TED. The controller may be configured to selectivelyand separately activate each of said TEDs to deliver one or more thermalwaveforms to the vestibular system and/or the nervous system of thepatient. In some embodiments, the controller is configured to generate aprescription comprising a set of instructions for delivering one or morethermal waveforms to the vestibular system and/or the nervous system ofthe patient and to activate the TEDs to deliver the prescribed thermalwaveform(s).

The vestibular stimulation device may comprise one or more heat sinks.In some embodiments, at least one heat sink is thermally coupled to eachearpiece. In some embodiments, each TED thermally coupled to an earpieceis thermally coupled between the earpiece and at least one heat sink.

The vestibular stimulation device may comprise one or more sensors. Insome embodiments, the sensor(s) is/are configured to provide feedbackdata to the controller. In some such embodiments, the controller isconfigured (e.g., with computer instructions (i.e., software)) to adjustone or more attributes of TED activation (e.g., magnitude, duration,wave pattern, etc.) in response to feedback data received from thesensor(s) with which it is associated. For example, the vestibularstimulation device may be configured such that, during delivery of athermal waveform, the controller activates the TED(s) in a continuous orsubstantially continuous manner and repeatedly, continuously orsubstantially continuously adjusts one or more attributes of TEDactivation in response to feedback data received from one or moresensors (e.g., a temperature sensor configured to provide feedback dataassociated with the temperature of the ear canal of a patient).

The vestibular stimulation device may comprise a headband. In someembodiments, the headband is configured to position the earpiece(s) inthe ear canal(s) of a patient.

As shown in FIG. 1, in some embodiments, the vestibular stimulationdevice 1 comprises a controller 11, a pair of earpieces 12 a, 12 b, apair of TEDs 13 a, 13 b and a pair of heat sinks 15 a, 15 b, wherein oneTED 13 a is thermally connected between one heat sink 15 a and anearpiece 12 a that is configured so as to be insertable into the leftear canal of a patient, wherein the other TED 13 b is thermallyconnected between the a heat sink 15 b and an earpiece 12 b that isconfigured so as to be insertable into the right ear canal of a patientand wherein the controller 11 is operatively connected to each of theTEDs 13 a, 13 b by a thermal stimulation conductive line 16 a, 16 b. Insome such embodiments, each earpiece 12 a, 12 b is operatively connectedto a sensor 14 a, 14 b (e.g., each earpiece may be thermally connectedto a temperature sensor that is configured to detect the temperature ofthe earpiece), and each of the sensors 14 a, 14 b is operativelyconnected to the controller 11 by a wireless connection 17 a, 17 b(using a radiofrequency transceiver or a Bluetooth connection, forexample).

I. Controller

Any suitable controller can be used to carry out the present invention,including, but not limited to, those described in U.S. PatentPublication Nos. 2010/0198204 and 2010/0198282; in U.S. patentapplication Ser. Nos. 12/970,312 and 12/970,347 and in U.S. ProvisionalApplication Nos. 61/497,761, the disclosure of each of which isincorporated herein by reference in its entirety.

The controller may be configured to activate at least one TED. In someembodiments, the controller is configured to activate at least one TEDto deliver one or more thermal waveforms to the vestibular system and/orthe nervous system of a patient (e.g., by heating and/or cooling theearpiece(s) that is/are thermally coupled to the TED. For example, thecontroller may be configured to activate the TED(s) based upon aprescription comprising a set of instructions for delivering one or morethermal waveforms to the vestibular system and/or the nervous system ofa patient (i.e., the controller may be configured to activate the TED(s)so as to deliver the prescribed thermal waveform(s) to the vestibularsystem and/or the nervous system of the patient).

The controller may be configured to selectively and separately activatea plurality of TEDs. For example, the controller may be configured toselectively and separately activate the TED(s) thermally coupled to anearpiece inserted into the left ear canal of a patient and the TED(s)thermally coupled to an earpiece inserted into the right ear canal of apatient (e.g., to deliver a thermal waveform only to the left ear canalof the patient, to deliver a thermal waveform only to right ear canal ofthe patient or to simultaneously deliver different thermal waveforms tothe left and right ear canals of the patient). Likewise, the controllermay be configured to separately activate a plurality of TEDs thermallycoupled to a single earpiece.

The controller may be configured to activate the TED(s) in any suitablemanner, including, but not limited to, activation with direct currentand/or electrical pulses. In some embodiments, the controller isconfigured to activate the TED(s) in a continuous or substantiallycontinuous manner, adjusting one or more parameters of TED activation(e.g., magnitude, duration, pulse width, etc.) to deliver the desiredthermal stimulus. For example, the controller may be configured suchthat it continuously or substantially continuously activates each of theTEDs with which it is operatively connected and delivers differentthermal stimuli by modulating the type and/or level of activationapplied to each TED.

The controller may be configured to activate the TED(s) to deliver anysuitable thermal waveform or combination of thermal waveforms,including, but not limited to, those described in U.S. ProvisionalPatent Application Nos. 61/424,132, 61/498,096, 61/424,326, 61/498,080,61/498,911 and 61/498,943, the disclosure of each of which isincorporated herein by reference in its entirety. In some embodiments,the controller is configured to activate the TED(s) to deliver one ormore actively controlled, time-varying thermal waveforms to thevestibular system and/or the nervous system of a patient.

The controller may also be configured to activate the TED(s) to delivera constant thermal stimulus to the ear canal(s) of a patient. Forexample, the controller may be configured to activate the TED(s) so asto maintain the temperature of a patient's ear canal at a targettemperature (e.g., to hold a patient's right canal at 20 degreesCentigrade while a thermal waveform is delivered to the patient's leftcanal).

The controller may likewise be configured to deliver one or more placebowaveforms (i.e., to fool a patient into believing one or more thermalwaveforms has been delivered even though no such delivery has occurred).

In some embodiments, the controller is operatively connected to at leastone TED via a thermal stimulation conductive line. In those embodimentswherein the controller is operatively connected to a plurality of TEDs,the controller may be operatively connected to each TED via a separatethermal stimulation conductive line. In some such embodiments, each ofthe plurality of separate thermal stimulation conductive lines isbundled together into one or more thermal stimulation leads (e.g., thethermal stimulation conductive lines connected to the TED(s) thermallycoupled to the right earpiece may be bundled separately from the thermalstimulation conductive lines connected to the TED(s) thermally coupledto the left earpiece). In some such embodiments, each thermalstimulation lead is connected to the controller via a lead interface(e.g., one or more thermal stimulation leads may be connected to thecontroller using an 18-pin connector).

In some embodiments, the controller is operatively connected to at leastone TED via a wireless connection (using a radiofrequency transceiver ora Bluetooth connection, for example).

The controller may be configured to receive and/or transmit any suitabledata, including, but not limited to, data associated with theparameters, indications and/or approvals of one or more thermalwaveforms, data associated with one or more prescriptions, controllerfeedback data, data associated with the delivery of one or more thermalwaveforms, data associated with the fit of one or more earpieces,physician feedback data and/or patient information.

The controller may be configured to receive and/or transmit data from/tovarious devices, including, but not limited to, a patient controldevice, a physician control device, a physician support device, aregistry, a TED, a sensor and/or a portable memory device (e.g., an SDmemory card). In some embodiments, the controller is configured toreceive data associated with the parameters, indications and/orapprovals of one or more thermal waveforms (e.g., idealized thermalwaveforms) from a patient control device, a physician control device, aphysician support device, a registry and/or a portable memory device(e.g., an SD memory card); to receive one or more prescriptions from apatient control device, a physician control device, a physician supportdevice, a registry and/or a portable memory device (e.g., an SD memorycard); to receive controller feedback data from one or more TEDs and/orone or more sensors; to receive data associated with the delivery of oneor more thermal waveforms (e.g., idealized thermal waveforms) from oneor more TEDs and/or one or more sensors; to transmit data associatedwith the delivery of one or more thermal waveforms (e.g., idealizedthermal waveforms) to a patient control device, a physician controldevice, a physician support device, a registry and/or a portable memorydevice (e.g., an SD memory card); to transmit patient feedback data to aphysician support device, a registry and/or a portable memory device(e.g., an SD memory card) and/or to transmit patient information to aphysician control device, a physician support device, a registry and/ora portable memory device (e.g., an SD memory card).

The controller may be configured to receive and/or transmit data overany suitable wired or wireless communications channel, including, butnot limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like.

In some embodiments, the controller comprises memory, a processor and apower supply. As will be appreciated by one of skill in the art, theprocessor may be any commercially available or custom microprocessor.Memory can include, but is not limited to, the following types ofdevices: cache, ROM, PROM, EPROM, EEPROM, flash memory, SRAM and DRAM.The power supply may be an internal power supply (e.g., one or morerechargeable batteries that may be recharged without first being removedfrom the controller).

The controller's memory may comprise any suitable software and/or data,including, but not limited to, an operating system, applications, dataand input/output (I/O) drivers.

As will be appreciated by one of skill in the art, the controller mayuse any suitable operating system, including, but not limited to, OS/2,AIX, OS/390 or System390 from International Business Machines Corp.(Armonk, N.Y.), Window CE, Windows NT, Windows95, Windows98,Windows2000, Windows 7 or Windows Vista from Microsoft Corp. (Redmond,Wash.), Mac OS from Apple, Inc. (Cupertino, Calif.), Unix, Linux orAndroid.

As will be appreciated by one of skill in the art, the controller maycomprise any suitable application, including, but not limited to, one ormore programs configured to implement one or more of the variousfeatures of the present invention. For example, the controller maycomprise a waveform module that enables a user to generate and/or modifythe parameters, indications and/or approvals of one or more thermalwaveforms; a treatment module that enables a user to generate, modify,update and/or extend a prescription comprising a set of instructions fordelivering one or more thermal waveforms to the vestibular system and/orthe nervous system of a patient; a control module configured to activateone or more TEDs; a network module configured to receive and/or transmitdata; a GUI module configured to display information and/or accept userinput; a feedback module configured to receive, transmit, and/or analyzecontroller feedback data, data associated with the delivery of one ormore thermal waveforms, data associated with the fit of one or moreearpieces, physician feedback data and/or patient information; an alertgeneration module configured to generate one or more alert messages; atone generation module configured to produce one or more audible tones;a visual indicator module configured to produce one or more visualindicators; an impedance module configured to detect and/or monitor theimpedance between an earpiece inserted into the ear canal of a patientand an electrode affixed to a second location on/in said patient's body,a security module configured to prevent unauthorized use of thecontroller and/or a safety module configured to deactivate thecontroller in the event of a system malfunction and/or failure. In someembodiments, two or more of the aforementioned modules are combined toform a single module configured to carry out the function(s) of each ofthe individual modules (e.g., the controller may comprise awaveform-treatment module that enables a user to generate and/or modifyone or more thermal waveforms and to generate, modify, update and/orextend a prescription). In some embodiments, one of the aforementionedmodules is split into two or more distinct modules (e.g., the controllermay comprise a waveform generation module that enables a user togenerate the parameters, indications and/or approvals of one or morethermal waveforms and a waveform update module that enables a user tomodify the parameters, indications and/or approvals of one or morethermal waveforms). In some embodiments, one or more of the functionsdescribed below with respect to one of the modules described below isperformed by one of the other modules described below (e.g., the controlmodule, rather than the feedback module, may be configured toreceive/analyze controller feedback data).

A. Waveform Module

In some embodiments, the controller comprises a waveform module wherebya user may generate and/or modify the parameters, indications and/orapprovals of one or more thermal waveforms.

In some embodiments, the waveform module comprises software that enablesa user to generate and/or modify the parameters of one or more thermalwaveforms by point-to-point design and/or by utilizing mathematicalfunctions. For example, the waveform module may comprise software thatenables a user to generate and/or modify the parameters, indicationsand/or approvals of a thermal waveform by selecting/altering one or moreparameters, including, but not limited to, shape, frequency, amplitudeand duration. In some embodiments, the waveform module enables a user toretrieve/select a thermal waveform from a database and then modify theparameters of that thermal waveform to generate a new thermal waveform.

In some embodiments, the waveform module comprises software that enablesa user to generate and/or modify the parameters, indications and/orapprovals of one or more thermal waveforms using an interactive touchscreen. For example, the waveform module may comprise software thatenables a user to generate the parameters of a thermal waveform bydrawing the desired waveform on an interactive touch screen (FIG. 3).Similarly, the waveform module may enable a user to modify theparameters of a thermal waveform by highlighting one or more points onthe waveform and moving the point(s) to a new location (e.g., ahigher/lower temperature) (FIG. 4).

In some embodiments, the waveform module comprises software thatautomatically adjusts the parameters of the thermal waveform(s) createdby a user to account for system limitations. For example, the waveformmodule may comprise software that automatically adjusts the slope of athermal waveform in accordance with the minimum/maximum temperatureand/or the rate of temperature change that is achievable using aparticular combination of earpiece(s), TED(s), etc. That is, thewaveform module may comprise software that prevents a user fromgenerating parameters for a thermal waveform that cannot be deliveredbecause of system limitations.

In some embodiments, the waveform module comprises software that enablesa user to protect one or more thermal waveforms (i.e., to prevent one ormore users from modifying the parameters, indications and/or approvalsof the thermal waveform(s) and/or from deleting the thermal waveform(s)from a waveform database). For example, the waveform module may comprisesoftware that enables a user to protect one or more idealized thermalwaveforms (e.g., by requiring users to enter a specified password priorto modifying and/or deleting the idealized thermal waveform(s)).

In some embodiments, the waveform module comprises software that enablesa user to remove the protected status from one or more thermalwaveforms. For example, the waveform module may comprise software thatenables a user to remove the protected status from one or more idealizedthermal waveforms (e.g., by entering the appropriate password).

In some embodiments, the waveform module is configured to automaticallygenerate and/or modify the parameters, indications and/or approvals ofone or more thermal waveforms (e.g., idealized thermal waveforms) inresponse to data received from one or more devices/modules. For example,the waveform module may be configured to automatically update one ormore thermal waveforms responsive to data received from one or more TEDsand/or one or more sensors.

The waveform module may be configured to retrieve the parameters,indications and/or approvals of one or more thermal waveforms from anysuitable database, including, but not limited to, a waveform databaseresiding in the controller, a waveform database residing in a patientcontrol device, a waveform database residing in a physician controldevice, a waveform database residing in a physician support device, awaveform database residing in a registry and/or a waveform databaseresiding in a portable memory device (e.g., an SD memory card).

Waveform parameters, indications and/or approvals generated and/ormodified by the waveform module may be stored in a database. In someembodiments, the generated/modified parameters, indications and/orapprovals are stored in a waveform database comprising data associatedwith the parameters, indications and/or approvals of one or more thermalwaveforms (e.g., idealized thermal waveforms). For example, thegenerated/modified waveform parameters, indications and/or approvals maybe stored in a waveform database residing in the controller, a waveformdatabase residing in a patient control device, a waveform databaseresiding in a physician control device, a waveform database residing ina physician support device, a waveform database residing in a registryand/or a waveform database residing in a portable memory device (e.g.,an SD memory card).

B. Treatment Module

In some embodiments, the controller comprises a treatment module wherebya user (e.g., a physician) may generate, modify, update and/or extend aprescription. For example, the treatment module may enable a user togenerate, modify, update and/or extend a prescription comprising a setof instructions for delivering one or more thermal waveforms to thevestibular system and/or the nervous system of a patient.

In some embodiments, the treatment module comprises software thatenables a user to select one or more thermal waveforms from a database(e.g., an idealized thermal waveform from an idealized waveformdatabase) and to provide instructions as to when/how each of thosewaveforms should be administered. For example, a treatment module maycomprise software that enables a user to provide instructions as to howlong a treatment schedule is to last (FIG. 5), to provide instructionsas to how many treatments may be administered each day (FIG. 5), toprovide instructions as to how often each thermal waveform is to beadministered (FIG. 6), to provide instructions as to what time(s) of dayeach thermal waveform is to be administered (FIGS. 6 and 9), to selectone or more idealized thermal waveforms from a database (FIG. 7), toprovide instructions regarding whether each of the selected thermalwaveforms is to be delivered to the right and/or left ear canal of apatient (FIG. 8), etc.

In some embodiments, the treatment module comprises software thatenables a user to modify, update and/or extend a prescription bychanging one or more parameters of the prescription (FIG. 10),including, but not limited to, which thermal waveform(s) are delivered,frequency with which the thermal waveform(s) is/are delivered, and theexpiration date of the prescription. Any suitable prescription may bemodified, updated and/or extended, including, but not limited to,prescriptions stored in a prescription database (e.g., a prescriptiondatabase residing in the controller, in a patient control device, in aphysician control device, in a physician support device, in a registryor in a portable memory device, such as a portable SD memory card).

The treatment module may be configured to retrieve/select thermalwaveforms from any suitable database, including, but not limited to, awaveform database residing in the controller, a waveform databaseresiding in a patient control device, a waveform database residing in aphysician control device, a waveform database residing in a physiciansupport device, a waveform database residing in a registry and/or awaveform database residing in a portable memory device (e.g., an SDmemory card).

The treatment module may be configured to retrieve prescriptions fromany suitable database, including, but not limited to, a prescriptiondatabase residing in the controller, a prescription database residing ina patient control device, a prescription database residing in aphysician control device, a prescription database residing in aphysician support device, a prescription database residing in a registryand/or a prescription database residing in a portable memory device(e.g., an SD memory card).

Prescriptions generated, modified, updated and/or extended by thetreatment module may be added to a database comprising one or moreprescriptions. For example, the prescriptions may be stored in aprescription database residing in the controller, a prescriptiondatabase residing in a patient control device, a prescription databaseresiding in a physician control device, a prescription database residingin a physician support device, a prescription database residing in aregistry and/or a prescription database residing in a portable memorydevice.

C. Control Module

In some embodiments, the controller comprises a control moduleconfigured to activate at least one TED (i.e., to control the magnitude,duration, waveform and other attributes of stimulation delivered by theat least one TED). The control module may be configured to activate theTED(s) to deliver any suitable thermal waveform or combination ofthermal waveforms, including, but not limited to, those described inU.S. Provisional Patent Application Nos. 61/424,132, 61/498,096,61/424,326, 61/498,080, 61/498,911 and 61/498,943, the disclosure ofeach of which is incorporated herein by reference in its entirety.

In some embodiments, the control module is configured to selectively andseparately activate a plurality of TEDs (e.g., by activating only one ofsaid plurality of TEDs, by heating one TED and cooling another, bysequentially activating the TEDs, by activating different TEDs usingdifferent temperature/timing parameters, combinations of some or all ofthe foregoing, etc.).

In some embodiments, the control module is configured to activate theTED(s) based upon a prescription. For example, the control module may beconfigured to activate one or more TEDs based upon a prescriptioncomprising a set of instructions for delivering one or more thermalwaveforms to the vestibular system and/or the nervous system of apatient.

In some embodiments, the control module is configured to receive and/orretrieve instructions for delivering a thermal waveform from a database.For example, the control may be configured to receive and/or retrieve aprescription comprising a set of instructions for delivering one or morethermal waveforms to the vestibular system and/or the nervous system ofa patient from a prescription database residing in the controller, froma prescription database residing in a patient control device, from aprescription database residing in a physician control device, from aprescription database residing in a physician support device, from aprescription database residing in a registry and/or from a prescriptiondatabase residing in a portable memory device (e.g., an SD memory card).

In some embodiments, the control module is configured to adjust one ormore attributes of TED activation (e.g., magnitude, duration, wavepattern, etc.) in response to controller feedback data received from oneor more TEDs and/or one or more sensors. For example, the control modulemay be configured to increase/decrease the magnitude of TED activationin response to controller feedback data indicating that an earpiece thatis thermally coupled to the TED has not yet reached a target temperature(e.g., the control module may be configured to increase the currentflowing through the TED in response to controller feedback dataindicating that the temperature of the earpiece has not yet dropped tothe target temperature in response to a cooling waveform).

D. Network Module

In some embodiments, the controller comprises a network moduleconfigured to receive, retrieve and/or transmit data.

The network module may be configured to receive, retrieve and/ortransmit data from/to any suitable device/module/database, including,but not limited to, other modules residing in the controller, databasesresiding in the controller, a patient control device, a physiciancontrol device, a physician support device, a registry, a TED, a sensorand a portable memory device (e.g., an SD memory card).

The network module may be configured to receive, retrieve and/ortransmit data over any suitable wired or wireless communicationschannel, including, but not limited to, a LAN, the Internet, a publictelephone switching network, Bluetooth, WLAN and the like.

The network module may be configured to receive, retrieve and/ortransmit any suitable data, including, but not limited to, dataassociated with the parameters, indications and/or approvals of one ormore thermal waveforms, one or more prescriptions, controller feedbackdata, data associated with the delivery of one or more thermalwaveforms, data associated with the fit of one or more earpieces,patient feedback data, physician feedback data and/or patientinformation.

In some embodiments, the network module is configured to receive and/orretrieve data associated with the parameters, indications and/orapprovals of one or more thermal waveforms from a waveformmodule/database residing in the controller, from a patient controldevice, from a physician control device, from a physician supportdevice, from a registry and/or from a portable memory device.

In some embodiments, the network module is configured to receive and/orretrieve one or more prescriptions from a treatment module residing inthe controller, from a prescription database residing in the controller,from a patient control device, from a physician control device, from aphysician support device, from a registry and/or from a portable memorydevice.

In some embodiments, the network module is configured to receive and/orretrieve controller feedback data, data associated with the delivery ofone or more thermal waveforms and/or data associated with the fit of oneor more earpieces from a control module residing in the controller, froman impedance module residing in the controller, from a feedbackmodule/database residing in the controller, from one or more TEDs and/orfrom one or more sensors.

In some embodiments, the network module is configured to receive and/orretrieve patient feedback data, physician feedback data and/or patientinformation from a feedback module/database residing in the controller,from a GUI module residing in the controller, from a patient informationdatabase residing in the controller, from a patient control device, froma physician control device, from a physician support device, from aregistry and/or from a portable memory device.

In some embodiments, the network module is configured to transmit dataassociated with the parameters, indications and/or approvals of one ormore thermal waveforms to a waveform module/database residing in thecontroller, to a treatment module residing in the controller, to apatient control device, to a physician control device, to a physiciansupport device, to a registry and/or a to portable memory device.

In some embodiments, the network module is configured to transmit one ormore prescriptions to a treatment module residing in the controller, toa prescription database residing in the controller, to a patient controldevice, to a physician control device, to a physician support device, toa registry and/or to a portable memory device.

In some embodiments, the network module is configured to transmitcontroller feedback data, data associated with the delivery of one ormore thermal waveforms and/or data associated with the fit of one ormore earpieces to a control module residing in the controller, to afeedback module/database residing in the controller, to a patientcontrol device, to a physician control device, to a physician supportdevice, to a registry and/or to a portable memory device.

In some embodiments, the network module is configured to transmitpatient feedback data, physician feedback data and/or patientinformation to a feedback module/database residing in the controller, toa patient information database residing in the controller, to a patientcontrol device, to a physician control device, to a physician supportdevice, to a registry and/or to a portable memory device.

In some embodiments, the network module is configured to access adatabase comprising data associated with the parameters, indicationsand/or approvals of one or more thermal waveforms (e.g., idealizedthermal waveforms). For example, the network module maybe configured toaccess a waveform database residing in the controller, a waveformdatabase residing in a patient control device, a waveform databaseresiding in a physician control device, a waveform database residing ina physician support device, a waveform database residing in a registryand/or a waveform database residing in a portable memory device.

In some embodiments, the network module is configured to access adatabase comprising one or more prescriptions. For example, the networkmodule maybe configured to access a prescription database residing inthe controller, a prescription database residing in a patient controldevice, a prescription database residing in a physician control device,a prescription database residing in a physician support device, aprescription database residing in a registry and/or a prescriptiondatabase residing in a portable memory device.

In some embodiments, the network module is configured to access adatabase comprising controller feedback data, data associated with thedelivery of one or more thermal waveforms, data associated with the fitof one or more earpieces, patient feedback data and/or physicianfeedback data. For example, the network module maybe configured toaccess a feedback database residing in the controller, a feedbackdatabase residing in a patient control device, a feedback databaseresiding in a physician control device, a feedback database residing ina physician support device, a feedback database residing in a registryand/or a feedback database residing in a portable memory device.

In some embodiments, the network module is configured to access adatabase comprising patient information. For example, the network modulemaybe configured to access a patient information database residing inthe controller, a patient information database residing in a patientcontrol device, a patient information database residing in a physiciancontrol device, a patient information database residing in a physiciansupport device, a patient information database residing in a registryand/or a patient information database residing in a portable memorydevice.

E. Graphical User Interface Module

In some embodiments, the controller comprises a GUI module configured todisplay information and/or to accept user input. Any suitable GUI may beused, including, but not limited to, a keyboard, a mouse, an LCD displaywith one or more associated entry keys and an interactive touch screen.For example, the GUI may comprise a static pressure touch-sensitivedisplay, a capacitive touch-sensitive display, a resistivetouch-sensitive display, an electrostatic capacity proximity sensor, amagnetic proximity sensor and/or an infrared proximity sensor. See,e.g., U.S. Patent Publication Nos. 2011/0271222, 2011/0273575,2011/0275414 and 2011/0275416.

The GUI module may be configured to display any suitable information,including, but not limited to, data associated with the delivery of oneor more thermal waveforms. For example, the GUI module may be configuredto display the current date and/or time (FIG. 10); the currenttemperature(s) of the earpiece(s) associated with the controller; thecurrent temperature(s) of a patient's ear canal(s); the currenttemperature(s) of a patient's inner ear(s); the current temperature(s)of the heat sink(s) associated with the controller; one or more targettemperatures (FIG. 11); the amount of time that has elapsed since theonset of delivery of one or more thermal waveforms (FIG. 11); the amountof time remaining in the delivery of one or more thermal waveforms (FIG.11); the amount of time that has elapsed since the onset of a treatmentsession; the amount of time remaining in a treatment session; agraphical representation of the thermal waveform being applied (FIG.11); the number of treatment sessions that have been administered for aprescription; the number of treatment sessions remaining in aprescription; the amount of time remaining until a prescription must berenewed/updated; the amount of remaining battery life, an alert message(e.g., a reminder to a patient that he/she is due for a treatmentsession); the target time/temperature parameters of one or moreprescribed thermal waveform(s) (FIG. 11); the precise time/temperatureparameters of the thermal waveform(s) delivered to a patient; thedate/time of delivery of the thermal waveform(s) delivered to a patient;the temperature(s) of a patient's ear canal(s) at various time pointsbefore, during and/or after delivery of the thermal waveform(s); thetemperature(s) of a patient's inner ear(s) at various time pointsbefore, during and/or after delivery of the thermal waveform(s); the fitof the earpiece(s) at various time points before, during and/or afterdelivery of the thermal waveform(s); an estimate of the thermal contactbetween the earpiece(s) and the patient's ear canal(s) at various timepoints before, during and/or after delivery of the thermal waveform(s);patient-specific time constants (e.g., a time constant associated withthe transduction of heat from a patient's ear canal to the inner ear);reaction time (i.e., how long it took for a patient to react to one ormore thermal waveforms); the effectiveness of one or more thermalwaveforms (i.e., whether and to what extent symptoms were relieved,whether the thermal waveform(s) enhanced the effectiveness of anotheragent/therapy, etc.); the stability of a treatment (i.e., how long theeffects of the treatment lasted); the instability of a treatment (i.e.,which symptom(s) returned and when did it/they return); the presence orabsence of comorbid disorders, injuries and/or diseases; disorder,injury and/or disease modulation(s) and/or modification(s) that occurredas a result of treatment; the cognitive effect(s) of one or more thermalwaveforms; patient compliance (e.g., whether a patient initiateddelivery at the prescribed time, whether a patient completed theprescribed treatment session, whether the earpiece(s) remained properlyfitted in a patient's ear canal(s) for the duration of the treatmentsession, etc.); the mood of a patient at various time points before,during and/or after delivery of one or more thermal waveforms (e.g.,videos/images of a patient that may be used to assess mood); objectivesmeasures of efficacy (e.g., nystamography data, EEG data, MRI data,heart rate data, blood pressure data); subjective measures of efficacy(e.g., a patient-reported pain score); blood chemistry data (e.g., bloodA1c levels, blood glucose levels and blood cortisol levels); salivachemistry data (e.g., saliva cortisol levels); urine chemistry data(e.g., urine cortisol levels)), comments a patient made about his/hertreatment session(s) (e.g., comments made to a physician, submitted inresponse to an automated survey and/or recorded in a treatment diary);the impedance between an earpiece inserted into the ear canal of apatient and an electrode affixed to a second location on/in saidpatient's body (e.g., an electrode placed in or adjacent to thepatient's other ear canal); the rate at which a patient's inner earcools in response to a cooling stimulus (e.g., data from a temperaturesensor, such as thermistor, that monitors how quickly the inner earcools in response to a cooling waveform); the rate at which a patient'sinner ear warms in response to a warming stimulus (e.g., data from atemperature sensor, such as thermistor, that monitors how quickly theinner ear warms in response to a warming waveform) and/or patientcomments regarding the subjective fit of his/her earpiece(s).

The GUI module may be configured to accept any suitable user input,including, but not limited to, instructions for generating and/ormodifying the parameters, indications and/or approvals of a thermalwaveforms; instructions for generating, modifying, updating and/orextending a prescription; patient feedback, physician feedback and/orpatient information. For example, the GUI module may be configured toaccept a pain score and/or patient comments regarding the effectivenessof a treatment session.

In some embodiments, the GUI module is configured to allow a user toinitiate/stop a treatment session (e.g., by pushing/selecting anemergency shutoff button/icon) (FIG. 11).

F. Feedback Module

In some embodiments, the controller comprises a feedback moduleconfigured to receive, transmit and/or analyze data.

The feedback module may be configured to receive and/or transmit datafrom/to any suitable device/module/database, including, but not limitedto, other modules residing in the controller, databases residing in thecontroller, a patient control device, a physician control device, aphysician support device, a registry, a TED, a sensor and a portablememory device (e.g., an SD memory card).

The feedback module may be configured to receive and/or transmit dataover any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like.

The feedback module may be configured to receive, transmit and/oranalyze any suitable data, including, but not limited to, controllerfeedback data, data associated with the delivery of one or more thermalwaveforms, data associated with the fit of one or more earpieces,patient feedback data, physician feedback data and/or patientinformation.

In some embodiments, the feedback module is configured to receive and/oranalyze controller feedback data, data associated with the delivery ofone or more thermal waveforms and/or data associated with the fit of oneor more earpieces from an impedance module residing in the controller,from a feedback database residing in the controller, from one or moreTEDs and/or from one or more sensors. For example, the feedback modulemay be configured to analyze the accuracy with which one or moreprescribed waveforms was delivered to a patient, the fit of an earpiecebased upon the rate at which the temperature of the earpiece changes inresponse to a cooling/warming waveform, the slew rate associated withone or more TEDs, the impedance between an earpiece positioned in theleft ear canal of a patient and an earpiece positioned in the right earcanal of a patient, the impedance between an earpiece positioned in theear canal of a patient and an electrode affixed to a second locationon/in the patient's body, etc.

In some embodiments, the feedback module is configured to receive and/oranalyze patient feedback data, physician feedback data and/or patientinformation from a GUI module residing in the controller, from afeedback database residing in the controller, from a patient informationdatabase residing in the controller, from a patient control device, froma physician control device, from a physician support device, from aregistry and/or from a portable memory device. For example, the feedbackmodule may be configured to analyze the effectiveness of a given thermalwaveform or combination of thermal waveforms (e.g., by analyzing painscores entered before, during and after a treatment session), theeffect(s) of one or more waveform modifications (e.g., by analyzingwhether/how much a given waveform modification changed the effectivenessof a thermal waveform in treating a disease/disorder), etc.

In some embodiments, the feedback module is configured to transmitcontroller feedback data, data associated with the delivery of one ormore thermal waveforms, data associated with the fit of one or moreearpieces, patient feedback data, physician feedback data, patientinformation and/or data associated with its analysis to a control moduleresiding in the controller, to a feedback database residing in thecontroller, to a patient information database residing in thecontroller, to a patient control device, to a physician control device,to a physician support device, to a registry and/or to a portable memorydevice (e.g., an SD memory card).

G. Alert Generation Module

In some embodiments, the controller comprises an alert generation moduleconfigured to generate one or more alert messages.

The alert generation module may be configured to generate any suitablealert message, including, but not limited to, a reminder that a patientis due for a treatment session; a reminder that a patient must enterpatient feedback data (e.g., a pain score) following a treatmentsession; an indication of the number of treatment sessions remaining ina prescription; an error message indicating that a treatment session hasbeen interrupted due to a system error; an alert indicating that one ormore idealized thermal waveforms has been modified; an alert indicatingthat a given modification is likely to increase/decrease theeffectiveness of a given thermal waveform and/or an alert indicatingthat a given thermal waveform, class of thermal waveforms or combinationof thermal waveforms has been identified as being indicated and/orapproved for use in the treatment of a disease/disorder; a reminder thata patient must contact his/her physician to update/extend his/herprescription and a warning that the controller's internal power supplyis low.

In some embodiments, the alert generation module is configured tocommunicate with various devices/modules, including, but not limited to,a patient control device, a physician control device, a physiciansupport device, a TED, a sensor, a portable memory device (e.g., an SDmemory card) and other modules of the controller. For example, the alertgeneration module may be configured to provide instructions to the GUImodule and/or the tone generation module for displaying one or morealert messages and/or for generation an audible tone to alert a user ofthe presence of the one or more alert messages. The graphical userinterface module may be configured to display the one or more alertmessages immediately upon generation or upon interaction with a user(e.g., an alert notification icon may be generated, with the alertmessage being displayed only after the user indicates that he/she wishesto view the message).

H. Tone Generation Module

In some embodiments, the controller comprises a tone generation moduleconfigured to produce audible tones. In some such embodiments, the tonegeneration module comprises a piezo buzzer. Audible tones may beproduced to alert a user to various circumstances/events, including, butnot limited to, the start of a treatment session, the end of a treatmentsession, interruption of a treatment session, low battery power and theexistence of an unread/unviewed alert message. Audible tones may begenerated repeatedly in response to a single circumstance/event (e.g.,an audible tone may be generated repeatedly until the user views/readsthe message) and may become progressively louder and/or more frequentwith time.

I. Visual Indicator Module

In some embodiments, the controller comprises a visual indicator moduleconfigured to notify a user of the existence of an unread/unviewed alertmessage and/or to notify the user that a treatment session is inprogress. In some such embodiments, the visual indicator modulecomprises an LED indicator light. The visual indicator module may beactivated repeatedly in response to a single alert message (e.g., an LEDlight may be illuminated repeatedly until the user views/reads themessage) or may remain activated until the user views/reads the message.In some preferred embodiments, an LED indicator light may be illuminatedthroughout a treatment session and deactivated upon completion of thetreatment session, and may change color to signal various events withina treatment session (e.g., the light may appear blue during coolingperiods and appear red during heating periods).

J. Impedance Module

In some embodiments, the controller comprises an impedance moduleconfigured to detect and/or monitor the impedance and/or capacitancebetween an earpiece inserted into the ear canal of a patient and anelectrode affixed to a second location on/in said patient's body. Forexample, the impedance module may be configured to deliver an electricalcurrent to the earpiece and to measure and/or record the impedanceand/or capacitance between the earpiece and the electrode.

In some embodiments, the impedance module may be configured to detectand/or monitor the impedance and/or capacitance between an earpieceinserted into the right ear canal of a patient and an earpiece insertedinto the left ear canal of said patient. For example, the impedancemodule may be configured to deliver an electrical current to theearpiece inserted into the right ear canal of the patient and to measureand/or record the impedance and/or capacitance between the twoearpieces.

Without wishing to be bound by theory, it is believed that if each ofthe earpieces is in substantially good thermal contact with thepatient's ear canal, then the earpieces will also be in substantiallygood electrical contact with the patient's ear canals, and the patient'shead will substantially complete an electrical circuit between theearpieces. However, if either of the earpieces is not in substantiallygood thermal contact with the patient's ear canal, then there willgenerally be poor electrical contact with the patient's ear canal, andthe patient's head will not complete the electrical circuit between theearpieces and an open circuit will be detected by the impedance module.

The impedance value between an earpiece inserted into the ear canal ofthe patient and the electrode affixed to a second location (e.g., anearpiece inserted into the patient's other ear canal) may be used toestimate the thermal contact between the earpiece(s) and the patient'sear canal(s). In some embodiments, impedance values may be detected fora range of patients to determine a range of impedance values in which itmay be assumed that the earpiece(s) is/are in substantially good thermalcontact with the patient's ear canal(s). When a vestibular stimulationdevice is being fitted to a new patient, the impedance value may bedetected, and if the impedance value is within the acceptable range, itmay be assumed that there is substantially good thermal contact betweenthe earpiece(s) and the patient's ear canal(s). In some embodiments,when a vestibular stimulation device is being fitted to a new patient,the impedance value between the earpiece inserted into the right earcanal of the patient and the earpiece inserted into the left canal ofthe patient may be detected and used as a patient-specific baseline tolater determine whether the patient is using the vestibular stimulationdevice in the proper configuration (i.e., whether the earpieces areproperly fitted into the patient's ear canals during a given treatmentsession).

The impedance module may be configured to monitor the impedance valuebetween an earpiece inserted into the ear canal of a patient and anelectrode affixed to a second location on/in said patient's body (e.g.,between two earpieces), and the impedance values may be analyzed (e.g.,by a medical health professional or the impedance module) to determinewhether the earpiece(s) is/was properly fitted at various times before,during and/or after delivery of the thermal waveform(s). In someembodiments, the impedance module may be configured to provide feedbackto the user if/when the impedance value indicates that the earpiece(s)are not in substantially good thermal contact with the patient's earcanal(s). In this configuration, the impedance module may provide anestimation of a degree of thermal contact between the earpiece(s) andthe patient's ear canal(s) in real-time or in data recorded and analyzedat a later time.

The impedance module may be configured to provide controller feedbackdata to the control module so that the control module may modulate theamplitude of the waveform(s) delivered by the TED(s) responsive to thedegree of thermal contact between the earpiece(s) and the patient's earcanal(s). For example, if the impedance module determines that there isa poor fit and poor thermal contact between the earpiece(s) and the earcanal(s), then the control module may increase the thermal output of theTED(s) to compensate for the poor thermal contact.

K. Security Module

In some embodiments, the controller comprises a security moduleconfigured to prevent unauthorized use of the controller (i.e., toprevent unauthorized persons from using the vestibular stimulationdevice, to prevent authorized persons from using the vestibularstimulation device in an unauthorized manner, etc.).

The security module may be configured to prevent unauthorized use of thecontroller using any suitable means of security, including, but notlimited to, password protection and data encryption. For example, thesecurity module may be configured such that a user is required to inputa designated password prior to initializing treatment; generating and/ormodifying a thermal waveform, generating, modifying, updating and/orextending a prescription; entering/viewing patient feedback data;entering/viewing physician feedback data and/or entering/viewing patientinformation (FIG. 12). In some embodiments, prescriptions are providedin an encrypted format, and the security module is configured such thatthe prescriptions can only be decrypted by the vestibular stimulationdevice assigned to or belonging to the patient for whom the prescriptionwas generated. In some embodiments, prescriptions are provided in anencrypted format, and the security module is configured such that theprescriptions can only be decrypted by inputting a designated decryptionkey. In some embodiments, a patient may be required to purchase adecryption key and/or password for each treatment session, prescription,refill, etc.

L. Safety Module

In some embodiments, the controller comprises a safety module configuredto deactivate the controller in the event of a system malfunction and/orfailure.

The safety module may be configured to deactivate the controller for anysuitable reason, including, but not limited to, excessive heating and/orcooling of an earpiece, excessive heating and/or cooling of a heat sink,a loss of thermal coupling between an earpiece and the TED(s) with whichit is associated, a loss of thermal coupling between a heat sink and theTED(s) with which it is associated, patient noncompliance (e.g., if thepatient has removed the earpiece(s) during a treatment session) andfaulty signaling from the controller to the associated TED(s).

In some embodiments, the safety module is configured to deactivate thecontroller if/when the temperature of an earpiece surpasses a specifiedsafety threshold. For example, the safety module may be configured todeactivate the controller if/when the temperature of the earpiece dropsbelow about 10 degrees Centigrade and/or rises above about 50 degreesCentigrade.

In some embodiments, the safety module is configured to deactivate thecontroller if/when the temperature of a heat sink that is thermallycoupled to an earpiece surpasses a specified safety threshold. Forexample, the safety module may be configured to deactivate thecontroller if/when the temperature of the heat sink drops below about 5degrees Centigrade and/or rises above about 50 degrees Centigrade.

In some embodiments, the safety module is configured to deactivate thecontroller if/when one or more of the activation signals sent from thecontroller to the associated TED(s) indicates that the system is may beoperating outside of a predefined safety range. For example, the safetymodule may be configured to deactivate the controller if/when anactivation signal sent from the controller to an associated TED exceedsthe level of activation that would normally be required to deliver theprescribed thermal waveform in a properly functioning system.

As will be appreciated by one of skill in the art, the controller maycomprise any suitable data, including, but not limited to, static and/ordynamic data used by the operating system, applications, I/O devicedrivers and other software components, controller feedback data, dataassociated with the parameters, indications and/or approvals of one ormore thermal waveforms (e.g., idealized thermal waveforms), dataassociated with one or more prescriptions, data associated with thedelivery of one or more thermal waveforms, data associated with the fitof one or more earpieces, patient feedback data, physician feedback dataand patient information. For example, the controller may comprise awaveform database comprising data associated with the parameters,indications and/or approvals of one or more idealized thermal waveforms;a prescription database comprising data associated with one or moreprescriptions; a feedback database comprising controller feedback data,data associated with the delivery of one or more thermal waveforms tothe vestibular system and/or the nervous system of a patient, patientfeedback data and physician feedback data and/or a patient historydatabase comprising data associated with one or more patients. In someembodiments, two or more of the aforementioned databases are combined toform a single database comprising data from each of the individualdatabases (e.g., the controller may comprise a feedback-history databasecomprising data associated with the delivery of one or more thermalwaveforms and patient information). In some embodiments, one of theaforementioned databases is split into two or more distinct databases(e.g., the controller may comprise a controller feedback databasecomprising controller feedback data, a delivery feedback databasecomprising data associated with the specific parameters of the thermalwaveform(s) delivered to a patient, a patient feedback databasecomprising patient feedback data and a physician feedback databasecomprising physician feedback data). In some embodiments, one or more ofthe data types described below with respect to one of the databasesdescribed below is stored in one of the other databases described below(e.g., the patient information database, rather than the feedbackdatabase, may be configured to receive/store patient feedback data). Insome embodiments, data is transmitted, received and/or stored in acontrolled format (e.g., in a standardized format using forms/programssupplied by a physician support device or a registry). The controllermay be configured to transmit, receive and store data in a manner thatensures compliance with any and all applicable laws and/or regulations(e.g., the Health Insurance Portability and Accountability Act of 1996(P.L. 104-191; “HIPAA”)).

A. Waveform Database

In some embodiments, the controller comprises a waveform databaseconfigured to receive, store and/or transmit data associated with theparameters, indications and/or approvals of one or more thermalwaveforms (e.g, one or more idealized thermal waveforms). In some suchembodiments, the waveform database is configured such that one or moreof the thermal waveforms stored therein is/are protected (e.g., usersmay be prevented from modifying and/or deleting the idealized thermalwaveform(s) stored in the waveform database).

The waveform database may comprise any suitable type of memoryincluding, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flashmemory, SRAM and DRAM. In some embodiments, the waveform databasecomprises a portable memory device, such as an SD memory card or a USBmemory stick. For example, the waveform database may comprise an SDmemory card interface and one or more prescriptions may be stored on aportable SD memory card.

The waveform database may be configured to receive and/or transmit datafrom/to any suitable device/module/database, including, but not limitedto, modules residing in the controller, a patient control device, aphysician control device, a physician support device, a registry, a TED,a sensor and a portable memory device (e.g., an SD memory card).

The waveform database may be configured to receive and/or transmit dataover any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like.

B. Prescription Database

In some embodiments, the controller comprises a prescription databaseconfigured to receive, transmit and/or store one or more prescriptions,wherein each prescription comprising a set of instructions fordelivering one or more thermal waveforms to the vestibular system and/orthe nervous system of a patient.

The prescription database may comprise any suitable type of memoryincluding, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flashmemory, SRAM and DRAM. In some embodiments, the prescription databasecomprises a portable memory device, such as an SD memory card or a USBmemory stick. For example, the prescription database may comprise an SDmemory card interface and one or more prescriptions may be stored on aportable SD memory card.

The prescription database may be configured to receive and/or transmitdata from/to any suitable device/module/database, including, but notlimited to, modules residing in the controller, a patient controldevice, a physician control device, a physician support device, aregistry, a TED, a sensor and a portable memory device (e.g., an SDmemory card).

The prescription database may be configured to receive and/or transmitdata over any suitable wired or wireless communications channel,including, but not limited to, a LAN, the Internet, a public telephoneswitching network, Bluetooth, WLAN and the like.

C. Feedback Database

In some embodiments, the controller comprises a feedback databaseconfigured to receive, transmit and/or store feedback data.

The feedback database may comprise any suitable type of memoryincluding, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flashmemory, SRAM and DRAM. In some embodiments, the feedback databasecomprises a portable memory device, such as an SD memory card or a USBmemory stick. For example, the feedback database may comprise an SDmemory card interface and one or more prescriptions may be stored on aportable SD memory card.

The feedback database may be configured to receive and/or transmitfeedback data from/to any suitable device/module/database, including,but not limited to, modules residing in the controller, a patientcontrol device, a physician control device, a physician support device,a registry, a TED, a sensor and a portable memory device (e.g., an SDmemory card).

The feedback database may be configured to receive and/or transmit dataover any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like.

Feedback data may comprise any suitable data, including, but not limitedto, controller feedback data, data associated with the delivery of oneor more thermal waveforms, data associated with the fit of one or moreearpieces, patient feedback data, physician feedback data and/or patientinformation. For example, the feedback database may comprise a log filedetailing the target time/temperature parameters of one or moreprescribed thermal waveform(s); the time/temperature parameters of thethermal waveform(s) delivered to a patient; the date/time of delivery ofthe thermal waveform(s) delivered to a patient; the temperature(s) of apatient's ear canal(s) at various time points before, during and/orafter delivery of one or more thermal waveforms; the temperature(s) of apatient's inner ear(s) at various time points before, during and/orafter delivery of one or more thermal waveforms; the fit of one or moreearpieces at various time points before, during and/or after delivery ofone or more thermal waveforms; an estimate of the thermal contactbetween one or more earpieces and a patient's ear canal(s) at varioustime points before, during and/or after delivery of one or more thermalwaveforms; patient-specific time constants (e.g., a time constantassociated with the transduction of heat from a patient's ear canal tothe inner ear); a patient's reaction time (i.e., how long it took for apatient to react to one or more thermal waveforms); effectiveness of oneor more thermal waveforms (i.e., whether and to what extent symptomswere relieved, whether the thermal waveform(s) enhanced theeffectiveness of another agent/therapy, etc.); stability of a treatment(i.e., how long the effects of a treatment lasted); instability of atreatment (i.e., which symptom(s) returned and when did it/they return);the presence or absence of comorbid disorders, injuries and/or diseases;disorder, injury and/or disease modulation(s) and/or modification(s)that occurred as a result of treatment; the cognitive effect(s) of oneor more thermal waveforms; patient compliance (e.g., whether a patientinitiated delivery at the prescribed time, whether a patient completedthe prescribed treatment session, whether the earpiece(s) remainedproperly fitted in a patient's ear canal(s) for the duration of thetreatment session, etc.); the mood of a patient at various time pointsbefore, during and/or after delivery of one or more thermal waveforms(e.g., videos/images of a patient that may be used to assess mood);objectives measures of efficacy (e.g., nystamography data, EEG data, MRIdata, heart rate data, blood pressure data); subjective measures ofefficacy (e.g., a patient-reported pain score); blood chemistry data(e.g., blood A1c levels, blood glucose levels and blood cortisollevels); saliva chemistry data (e.g., saliva cortisol levels); urinechemistry data (e.g., urine cortisol levels)); comments a patient madeabout his/her treatment session(s) (e.g., comments made to a physician,submitted in response to an automated survey and/or recorded in atreatment diary); the impedance between an earpiece inserted into theear canal of a patient and an electrode affixed to a second locationon/in said patient's body (e.g., an electrode placed in or adjacent tothe patient's other ear canal); the rate at which an earpiece is cooledin response to a cooling stimulus (e.g., data from a temperature sensor,such as thermistor, that monitors how quickly the earpiece cools inresponse to a cooling waveform); the rate at which an earpiece is warmedin response to a warming stimulus (e.g., data from a temperature sensor,such as a thermistor, that monitors how quickly the earpiece warms inresponse to a warming waveform); the rate at which a patient's ear canaland/or inner ear cooled in response to a cooling stimulus (e.g., datafrom a temperature sensor, such as thermistor, that monitors how quicklythe ear canal and/or the inner ear cools in response to a coolingwaveform); the rate at which a patient's ear canal and/or inner earwarmed in response to a warming stimulus (e.g., data from a temperaturesensor, such as a thermistor, that monitors how quickly the ear canaland/or the inner ear warms in response to a warming waveform); patientcomments regarding the subjective fit of one or more earpieces;physician comments regarding the effectiveness of one or more thermalwaveforms and/or physician comments regarding the effect(s) of one ormore waveform modifications.

D. Patient History Database

In some embodiments, the controller comprises a patient history databaseconfigured to receive, transmit and/or store patient information.

The patient history database may comprise any suitable type of memoryincluding, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flashmemory, SRAM and DRAM. In some embodiments, the patient history databasecomprises a portable memory device, such as an SD memory card or a USBmemory stick. For example, the patient history database may comprise anSD memory card interface and one or more prescriptions may be stored ona portable SD memory card.

The patient history database may be configured to receive and/ortransmit data from/to any suitable device/module/database, including,but not limited to, modules residing in the controller, a patientcontrol device, a physician control device, a physician support device,a registry, a TED, a sensor and a portable memory device (e.g., an SDmemory card).

The patient history database may be configured to receive and/ortransmit data over any suitable wired or wireless communicationschannel, including, but not limited to, a LAN, the Internet, a publictelephone switching network, Bluetooth, WLAN and the like.

Patient information may comprise any suitable information that isassociated with a patient, including, but not limited to, the patient'smedical history, the patient's current symptoms (if any), the patient'spresent diagnosis (if any), the patient's current prescriptions (if any)and data associated with the delivery of one or more thermal waveformsto the vestibular system and/or the nervous system of the patient.

As will be appreciated by one of skill in the art, the controller maycomprise any I/O device drivers, including, but not limited to, softwareroutines accessed through the operating system by the applications tocommunicate with devices such as I/O ports, memory components, TEDsand/or sensors.

As will be appreciated by one of skill in the art, the controller may beconfigured (e.g., with computer instructions (i.e., software)) tooperate in a plurality of distinct modes. In each mode, the controllermay be configured to permit access to some modules, databases and/orfunctionalities and to prevent access to other modules, database and/orfunctionalities. For example, the controller may be configured tooperate in a patient mode, wherein the user is allowed to performpatient-oriented tasks, such as starting/stopping a treatment sessionand/or providing feedback regarding the effectiveness of a treatmentsession, but is prevented from accessing othermodules/databases/functionalities (e.g., the user may be preventedgenerating, modifying, updating and/or extending prescriptions).Similarly, the controller may be configured to operate in a physicianmode, wherein the user is allowed to perform physician-oriented tasks,such as generating, modifying, updating and/or extending a prescriptioncomprising a set of instructions for delivering one or more thermalwaveforms to the vestibular system and/or the nervous system of apatient, but is prevented from accessing othermodules/databases/functionalities (e.g., the user may be prevented fromgenerating and/or modifying one or more thermal waveforms). Likewise,the controller may be configured to operate in a researcher mode,wherein the user is allowed to perform researcher-oriented tasks, suchas generating and/or modifying one or more idealized thermal waveforms,but is prevented from accessing other modules/databases/functionalities(e.g., the user may be prevented from modifying the underlyingoperational parameters of the controller). In addition, the controllermay be configured to operate in an engineer mode, wherein the user isallowed to access all of the controller'smodules/databases/functionalities. Each mode may be protected via aunique security measure (e.g., the controller may be configured suchthat each mode is protected by a unique password).

As shown in FIGS. 13-15, in some embodiments of the present invention,the controller 11 comprises memory 110, a processor 111 and a powersupply 112 (e.g., an internal power supply), wherein memory 110 isrepresentative of the overall hierarchy of memory devices containingsoftware and data used to implement the functionality of the controller11 and wherein the processor 111 communicates with the memory 110 via anaddress/data bus 1100. In particular embodiments, memory 110 comprisesan operating system 110 a, applications 110 b (e.g., a waveform module11 a configured to generate and/or modify the parameters, indicationsand/or approvals of one or more thermal waveforms; a treatment module 11b configured to generate, modify, update and/or extend a prescriptioncomprising a set of instructions for delivering one or more thermalwaveforms to the vestibular system and/or the nervous system of apatient; a control module 11 c configured to activate at least one TEDto deliver one or more thermal waveforms to the vestibular system and/orthe nervous system of a patient; a network module 11 d configured toreceive and/or transmit data, a GUI module 11 e configured to displayinformation and/or accept user input and/or a feedback module 11 fconfigured to receive, transmit, and/or analyze data), data 110 c (e.g.,a waveform database 11 h comprising data associated with the parameters,indications and/or approvals of one or more thermal waveforms; aprescription database 11 i comprising at least one prescriptioncomprising a set of instructions for delivering one or more thermalwaveforms to the vestibular system and/or the nervous system of apatient; a feedback database 11 j comprising data associated with thedelivery of one or more thermal waveforms and/or a patient historydatabase 11 k comprising patient information) and I/O drivers 110 d. Insome such embodiments, data 110 c comprises one or more databases storedon a portable memory device. For example, data 110 c may comprise an SDmemory card interface and a portable SD memory card comprising awaveform database 11 h, a prescription database 11 i, a feedbackdatabase 11 j and/or a patient history database 11 k.

In some embodiments, the control module 11 c is configured to activateone or more TEDs to delivery of one or more thermal waveforms to thevestibular system and/or the nervous system of a patient. For example,the control module 11 c may be configured to activate the TED(s) basedupon a prescription stored in the prescription database 11 i. In somesuch embodiments, the prescription is stored on an SD memory cardinserted into an SD memory card interface.

In some embodiments, the network module 11 d is configured to receivedata associated with the parameters, indications and/or approvals of oneor more thermal waveforms from the waveform module 11 a, a patientcontrol device, a physician control device, a physician support device,a registry and/or a portable memory device (e.g., an SD memory card) andto transmit the data to the waveform database 11 h for storage. In somesuch embodiments, the data is stored on an SD memory card inserted intoan SD memory card interface.

In some embodiments, the network module 11 d is configured to retrievedata associated with the parameters, indications and/or approvals of oneor more thermal waveforms from the waveform database 11 h, a patientcontrol device, a physician control device, a physician support device,a registry and/or a portable memory device (e.g., an SD memory card) andto transmit the data to the waveform module 11 a and/or the treatmentmodule 11 b.

In some embodiments, the network module 11 d is configured to receiveone or more prescriptions from the treatment module 11 b, a patientcontrol device, a physician control device, a physician support device,a registry and/or a portable memory device (e.g., an SD memory card) andto transmit the prescription(s) to the prescription database 11 i forstorage. In some such embodiments, the prescription(s) is/are stored onan SD memory card inserted into an SD memory card interface.

In some embodiments, the network module 11 d is configured to retrieveone or more prescriptions from the prescription database 11 i, a patientcontrol device, a physician control device, a physician support device,a registry and/or a portable memory device (e.g., an SD memory card) andto transmit the prescription(s) to the treatment module 11 b and/or thecontrol module 11 c.

In some embodiments, the network module 11 d is configured to receivecontroller feedback data, data associated with the delivery of one ormore thermal waveforms and/or data associated with the fit of one ormore earpieces from the control module 11 c, one or more TEDs 13 a, 13b, one or more sensors 14 a, 14 b, a patient control device, a physiciancontrol device, a physician support device, a registry and/or a portablememory device (e.g., an SD memory card) and to transmit that data to thefeedback database 11 j for storage. In some such embodiments, the datais stored on an SD memory card inserted into an SD memory cardinterface.

In some embodiments, the network module 11 d is configured to receivepatient feedback data from the GUI module 11 e and to transmit that datato the feedback database 11 j for storage. In some such embodiments, thepatient information is stored on an SD memory card inserted into an SDmemory card interface.

In some embodiments, the network module 11 d is configured to retrievecontroller feedback data, data associated with the delivery of one ormore thermal waveforms, data associated with the fit of one or moreearpieces and/or patient feedback data from the feedback database 11 jand to transmit the data to the control module 11 c, the feedback module11 f, a patient control device, a physician control device, a physiciansupport device, a registry and/or a portable memory device (e.g., an SDmemory card).

In some embodiments, the network module 11 d is configured to receivepatient feedback data from the GUI module 11 e and to transmit that datato the feedback database 11 j for storage. In some such embodiments, thepatient information is stored on an SD memory card inserted into an SDmemory card interface.

In some embodiments, the network module 11 d is configured to retrievepatient feedback data from the feedback database 11 j and to transmitthe data to the feedback module 11 f, a patient control device, aphysician control device, a physician support device, a registry and/ora portable memory device (e.g., an SD memory card).

In some embodiments, the network module 11 d is configured to receivepatient information from the GUI module 11 e, a patient control device,a physician control device, a physician support device, a registryand/or a portable memory device (e.g., an SD memory card) and totransmit that data to the patient history database 11 k for storage. Insome such embodiments, the patient information is stored on an SD memorycard inserted into an SD memory card interface.

In some embodiments, the network module 11 d is configured to retrievepatient information from the patient history database 11 k and totransmit the patient information to a patient control device, aphysician control device, a physician support device, a registry and/ora portable memory device (e.g., an SD memory card).

FIG. 16 is an illustration of a controller of the present invention. Asshown therein, in some embodiments, the controller may comprise agraphical user interface 113 comprising an LCD display 113 a configuredto display data associated with the delivery of one or more thermalwaveforms and a treatment start/stop button 113 b whereby a patient mayinitiate and/or terminate a treatment session, an SD memory cardinterface 114 into which an SD memory card comprising a prescription maybe inserted, an LED indicator light 115 configured to notify a patientof the occurrence of various events (e.g., the start of a treatmentsession or the generation of an alert message), a USB interface 116configured to transmit/receive data and/or to recharge an internal powersupply, a lead interface 117 whereby a patient may operatively connectone or more thermal stimulation leads and an on/off button 118.

FIG. 17 is an illustration of another controller of the presentinvention. As shown therein, in some embodiments, the controller maycomprise a graphical user interface comprising an interactivetouchscreen 113 c, an SD memory card interface 114 into which an SDmemory card may be inserted, a USB interface 116 configured totransmit/receive data and/or to recharge an internal batter supply and alead interface 117 whereby a user may operatively connect one or morethermal stimulation leads.

II. Earpiece

The vestibular stimulation device may comprise one or more earpieces.Earpieces of the present invention may be configured so as to beinsertable into the left ear canal and/or the right ear canal of apatient.

Any suitable earpiece can be used to carry out the present invention,including, but not limited to, those described in U.S. PatentPublication Nos. 2010/0198204 and 2010/0198282; in U.S. patentapplication Ser. Nos. 12/970,312 and 12/970,347; in U.S. ProvisionalApplication Nos. 61/497,761 and in U.S. Pat. No. D645,455, thedisclosure of each of which is incorporated herein by reference in itsentirety.

Earpieces of the present invention may comprise any suitable material,including, but not limited to, a rigid, thermally conductive material(e.g., a metal or a metal alloy). For example, the earpiece(s) maycomprise aluminum or an aluminum alloy (e.g., 6061 aluminum).

Earpieces of the present invention may be of any suitable size/shape. Insome embodiments, the earpiece(s) comprise(s) a distal end configured soas to be insertable into the left ear canal and/or the right ear canalof a patient and a proximal end configured so as to be thermallyconnected to one or more TEDs. In some embodiments, each earpiece weighsbetween about 1 and about 10 grams (e.g., about 9 grams or less or about4 grams or less).

Earpieces of the present invention may possess any suitable heattransfer properties. In some embodiments, the earpiece(s) is/are moreefficiently heated than cooled. For example, the earpiece(s) may have aslew rate of about 15 degrees Centigrade per minute or greater duringdelivery of a cooling stimulus and a slew rate of about 20 degreesCentigrade per minute or greater during delivery of a warming stimulus.

Earpieces of the present invention may comprise a thermally conductivecovering. For example, a thermally conductive cushion may cover one ormore portions of the earpiece(s) (e.g., the portion of an earpiece thatis inserted into the ear canal of a patient during use may be covered ina thermally conductive cushioning material to increase thermal contactbetween the earpiece and the ear canal (i.e., by conforming to the shapeof the ear canal)). The thermally conductive covering may comprise anysuitable material, including, but not limited to, coating materials thatmust be reapplied to the earpiece(s) before each use (e.g., water,water-based lubricants, thermal grease, gels and the like) and reusablecoating materials (e.g., a thermally conductive plastic sheath orsleeve).

Earpieces of the present invention may comprise a thermally insulatingcovering. For example, an insulating sleeve may cover one or moreportions of the earpiece(s) (e.g., the portion of an earpiece thatremains outside the ear canal of a patient during use may be covered inan insulating sleeve to reduce heat transfer between the earpiece andthe outer ear of the patient). The insulating covering may comprise anysuitable material, including, but not limited to, coating materials thatmust be reapplied to the earpiece(s) before each use (e.g., mineral oil,polypropylene, gels and the like) and reusable coating materials (e.g.,a thermally insulative sheath or sleeve). In some embodiments, thethermally insulating covering comprises a silicone sleeve.

Earpieces of the present invention may comprise an electricallyinsulating covering. For example, an electrically insulating coating maycover one or more portions of the earpiece(s) (e.g., the portion of anearpiece that is inserted into the ear canal of a patient during use maybe coated with an electrically insulating coating to prevent electricalconductance between the earpiece and the ear canal). The electricallyinsulating covering may comprises any suitable material, including, butnot limited to, metal oxides (e.g., aluminum oxide), glass, porcelainand composite polymer materials. In some embodiments, the surface of anearpiece comprising aluminum is anodized to produce an aluminum oxidecoating that electrically insulates the surface of the earpiece.

Earpieces of the present invention may comprise a protective coating.For example, a protective coating may cover one or more portions of theearpiece(s) (e.g., the portion of an earpiece that is inserted into theear canal of a patient during use may be coated with a protectivecoating to prevent the underlying surface of the earpiece from cominginto contact with the surface of the ear canal during use). Theprotective coating may comprise any suitable material, including, butnot limited to, metals and metal alloys (gold, silver, copper and alloysthereof).

As will be appreciated by one of skill in the art, earpieces of thepresent invention may comprise a single covering/coating that fulfillsmultiple purposes. For example, the a thermally conductive coatingapplied to the portion of an earpiece that is inserted into the earcanal of a patient during use may also prevent the underlying surface ofthe earpiece from coming into contact with the surface of the ear canalduring use.

As will be appreciated by one of skill in the art, earpieces of thepresent invention may comprise multiple coatings. For example, theearpiece(s) may comprise both a thermally conductive covering and athermally insulative covering (e.g., a thermally conductive cushion maycover the portion of an earpiece that is inserted into the ear canal ofa patient during use and an insulating sleeve may cover the portion ofan earpiece that remains outside the ear canal of a patient during use).

As shown in FIGS. 18A-18C, an earpiece 12 of the present invention maycomprise a base cavity 120, a tip cavity 121, one or more base apertures122, and a pressure-relief channel 123.

The base cavity 120 may be configured to receive a TED such that the TEDmay be thermally coupled to the earpiece 12 by mounting the TED on aninterior cavity surface of the base cavity 120.

The tip cavity 121 may be configured to receive a sensor (e.g., a sensorconfigured to detect the temperature of the earpiece).

The base apertures 122 may be configured to provide a passageway for oneor more wires and/or cables (e.g., a thermal stimulation lead connectedto a TED, a wire connected to the sensor 14, etc.).

The pressure-relief channel 123 may be configured to provide a pathwaythrough which air and/or moisture may flow during and/or after insertionof the earpiece 12 into the ear canal of a patient (e.g., to reduce thepressure in the ear canal during and/or after insertion of the earpiece12 and/or to allow moisture to escape the ear canal during and/or afterinsertion of the earpiece 12). The pressure-relief channel 123 may be ofany suitable length and depth (i.e., any length/depth that is sufficientto provide air flow from the interior of the ear canal at the distal tipof the earpiece to the external air outside of the ear canal duringand/or after insertion of the earpiece 12). For example, thepressure-relief channel 123 may be generally as long as a side of theearpiece 12 and may be about 0.5 mm to about 2.0 mm deep. Thepressure-relief channel 123 may be located in any suitable locationin/on the earpiece (e.g., embedded in an outer surface of earpiece 12 orpassing through the interior of the earpiece 12 so as to provide aconduit between the interior of the ear canal and the exteriorenvironment).

III. Thermoelectric Device

The vestibular stimulation device may comprise one or more TEDs. TEDs ofthe present invention may be operatively connected to one or morecontrollers and may be used deliver one or more thermal waveforms to thevestibular system and/or the nervous system of a patient (e.g., bywarming and/or cooling an earpiece inserted into the ear canal of saidpatient).

Any suitable thermoelectric device can be used to carry out the presentinvention, including, but not limited to, those described U.S. Pat. Nos.5,974,806, 6,229,123, 6,977,360, 7,024,865, 7,098,393, 7,202,443 and7,205,675; in U.S. Patent Publication Nos. 2004/0199266 and 2010/0198204and 2010/0198282; in U.S. patent application Ser. Nos. 12/970,312 and12/970,347 and in U.S. Provisional Application No. 61/497,761, thedisclosure of each of which is incorporated herein by reference in itsentirety. For example, the vestibular stimulation device comprises oneor more thin film TEDs (including, but not limited to, those describedin U.S. Pat. No. 6,300,150 and U.S. Patent Publication Nos. 2006/0086118and 2007/0028956).

TEDs of the present invention may comprise any suitable material. Forexample, the TED(s) may comprise a thermoelectric material such asbismuth telluride. In some embodiments, the TED(s) comprise a P-typethermoelectric element and an N-type thermoelectric element that areelectrically coupled in series and thermally coupled in parallel.

TEDs of the present invention may be of any suitable size/shape. In someembodiments, the TED(s) is/are of a generally rectangular shape, withtypical rectangular areas being about 2×1 mm or about 5×2 mm or more andwith a typical height profile of about 1.0 mm, about 0.65 mm or about0.5 mm or less.

TEDs of the present invention may be configured to sense the temperatureof the earpiece(s) and/or the heat sink(s) with which it is associated.

As will be appreciated by one of skill in the art, in those embodimentscomprising a plurality of TEDs, the TEDs may be arranged in any suitablemanner. For example, the TEDs may be positioned adjacent one another ina linear array, a two-dimensional array or a three-dimensional array(e.g., at a density of about 5, 10 or 20 per square centimeter to about100, 200 or 400 per square centimeter or more).

As will be appreciated by one of skill in the art, in those embodimentscomprising a plurality of TEDs, the TEDs may be thermally coupled to oneanother. For example, the TEDs may be thermally coupled to one another(e.g., through a common heat sink) such that thermal energy displaced byone TED can be at least partially offset by thermal energy displaced byanother TED (e.g., by heating tissue with one TED while cooling adjacenttissue with an adjacent TED).

IV. Heat Sink

The vestibular stimulation device may comprise one or more heat sinks.In some embodiments, at least one heat sink is thermally coupled to eachearpiece. In some embodiments, each TED thermally coupled to an earpieceis thermally coupled between the earpiece and at least one heat sink. Insome embodiments, the heat sink(s) may be thermally isolated from theearpiece(s) except insofar as they are thermally coupled to oppositesides of the TED(s). In those embodiments comprising a pair ofearpieces, each earpiece may be thermally coupled to a separate heatsink and/or to a common heat sink.

Any suitable heat sink can be used to carry out the present invention,including, but not limited to, those described in U.S. PatentPublication Nos. 2010/0198204 and 2010/0198282; in U.S. patentapplication Ser. Nos. 12/970,312 and 12/970,347 and in U.S. ProvisionalApplication No. 61/497,761, the disclosure of each of which isincorporated herein by reference in its entirety.

Heat sinks of the present invention may comprise any suitable material,including, but not limited to, metal alloys. For example, the heatsink(s) may comprise aluminum or an aluminum alloy (e.g., 6061aluminum).

Heat sinks of the present invention may be of any suitable size/shape.In some embodiments, the heat sink(s) comprise(s) a plurality of fins.Such fins may be from about 1 to about 500 mm in height, preferablyabout 1 to about 100 mm. In some embodiments, each heat sink weighsbetween about 30 grams and about 70 grams.

Heat sinks of the present invention may be passively and/or activelycooled. For example, each heat sink may be associated with one of morefans configured to increase air flow over the heat sink, therebyfacilitating heat dissipation from the heat sink.

V. Sensors

The vestibular stimulation device may comprise one or more sensors. Insome embodiments, the sensor(s) is/are configured to transmit controllerfeedback data, data associated with the delivery of one or more thermalwaveforms to the vestibular system and/or the nervous system of apatient and/or data associated with the fit of one or more earpieces tothe controller. In some such embodiments, the controller is configured(e.g., with computer instructions (i.e., software)) to adjust one ormore attributes of TED activation (e.g., magnitude, duration, wavepattern, etc.) in response to feedback data received from the sensor(s)with which it is associated. The sensor(s) may be configured to transmitdata to the controller over any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN, theInternet, a public telephone switching network, Bluetooth, WLAN and thelike.

Any suitable sensor can be used to carry out the present invention,including, but not limited to, those described in U.S. Pat. Nos.7,578,793, 7,558,622, 7,396,330, 7,215,994, 7,197,357, 7,087,075 and6,467,905; in U.S. Patent Publication No. 2010/0198282; in U.S. patentapplication Ser. Nos. 12/970,312 and 12/970,347 and in U.S. ProvisionalApplication No. 61/497,761, the disclosure of each of which isincorporated herein by reference in its entirety. For example, thevestibular stimulation device may comprise one or more of a galvanicskin resistance sensor, a position sensor, a motion detector, a bloodpressure sensor, a heart rate sensor, a blood gas level sensor, anelectrocardiogram sensor, an electroencephalogram sensor, anelectrooculogram sensor, an electronystragmography sensor, a breathingrate sensor, a nystagmus sensor and a temperature sensor. Numerous suchsensors are known and can be operatively associated with the systemsdescribed herein in accordance with known techniques or variationsthereof that will be apparent to those skilled in the art given thepresent disclosure.

In some embodiments, the vestibular stimulation device comprises one ormore temperature sensors. In some such embodiments, the vestibularstimulation device comprises a temperature sensor configured to providecontroller feedback data associated with the temperature of the heatsink, a temperature sensor configured to provide controller feedbackdata associated with the temperature of the earpiece, a temperaturesensor configured to provide controller feedback data associated withthe temperature of the ear canal of the patient and/or a temperaturesensor configured to provide controller feedback data associated withthe temperature of the inner ear of the patient. In some embodiments,each earpiece comprises a sensor (e.g., an infrared sensor) configuredto detect the temperature of the inner ear.

VI. Headband

The vestibular stimulation device may comprise a headband. In someembodiments, the headband is configured to position the earpiece(s) inthe ear canal(s) of a patient. In some embodiments the headband isadjustable. It should be appreciated that, while the headband may beworn over the head, it may also be positioned under the chin, behind thehead and/or over the ear(s).

Any suitable headband can be used to carry out the present invention,including, but not limited to, those described in U.S. patentapplication Ser. Nos. 12/704,872; 12/970,312 and 12/970,347 and in U.S.Provisional Application Nos. 61/287,873; 61/303,984, 61/304,059 and61/497,761, the disclosure of each of which is incorporated herein byreference in its entirety.

As noted above with respect to FIG. 1, the vestibular stimulation device1 may comprise a controller 11 that is operatively connected to a TED 13a that is thermally connected to an earpiece 12 a that is configured soas to be insertable into the left ear canal of a patient and to a TED 13b that is thermally connected to an earpiece 12 b that is configured soas to be insertable into the right ear canal of a patient. In some suchembodiments, the controller 11 (e.g., a controller 11 as described abovewith respect to FIG. 14) is configured to enable a user to deliver oneor more thermal waveforms to the vestibular system and/or the nervoussystem of a patient by:

-   -   a) generating and/or modifying the parameters, indications        and/or approvals of one or more thermal waveforms using the        waveform module 11 a;    -   b) transmitting the generated/modified parameters, indications        and/or approvals to the treatment module 11 b and/or storing the        generated/modified parameters, indications and/or approvals in        the waveform database 11 h;    -   c) generating a prescription comprising a set of instructions        for delivering one or more thermal waveforms to the vestibular        system and/or the nervous system of the patient by:        -   i) receiving one or more thermal waveforms from the waveform            module 11 a and providing instructions as to how each            thermal waveform is to be administered to the patient using            the treatment module 11 b; or        -   ii) selecting one or more thermal waveforms from the            waveform database 11 h and providing instructions as to how            each thermal waveform is to be administered to the patient            using the treatment module 11 b;    -   d) transmitting the generated prescription to the control module        11 c and/or storing the generated prescription in the        prescription database 11 i; and/or    -   e) delivering one or more thermal waveform(s) to the vestibular        system and/or the nervous system of the patient by:        -   i) receiving a prescription comprising a set of instructions            for delivering one or more thermal waveforms to the            vestibular system and/or the nervous system of the patient            from the treatment module 11 b and activating the TEDs 13 a,            13 b in accordance with the instructions; or        -   ii) retrieving a prescription comprising a set of            instructions for delivering one or more thermal waveforms to            the vestibular system and/or the nervous system of the            patient from the prescription database 11 i and activating            the TEDs 13 a, 13 b in accordance with the instructions.            In some such embodiments, the controller 11 (e.g., a            controller 11 as described above with respect to FIG. 15) is            configured to enable a user to deliver one or more thermal            waveforms to the vestibular system and/or the nervous system            of a patient by:    -   a) receiving and/or retrieving the parameters, indications        and/or approvals of one or more thermal waveforms from a patient        control device, a physician control device, a physician support        device, a registry and/or a portable memory device using the        network module 11 d;    -   b) storing the received/retrieved parameters, indications and/or        approvals in the waveform database 11 h and/or transmitting the        received/retrieved parameters, indications and/or approvals to        the waveform module 11 a and/or the treatment module 11 b;    -   c) generating and/or modifying the parameters, indications        and/or approvals of one or more thermal waveforms using the        waveform module 11 a;    -   d) transmitting the generated/modified parameters, indications        and/or approvals to the treatment module 11 b and/or storing the        generated/modified parameters, indications and/or approvals in        the waveform database 11 h;    -   e) receiving and/or retrieving a prescription from a patient        control device, a physician control device, a physician support        device, a registry and/or a portable memory device using the        network module 11 d;    -   f) storing the received/retrieved prescription in the        prescription database 11 i and/or transmitting the        received/retrieved prescription to the treatment module 11 b        and/or the control module 11 c;    -   g) generating a prescription comprising a set of instructions        for delivering one or more thermal waveforms to the vestibular        system and/or the nervous system of the patient by:        -   i) receiving one or more thermal waveforms from the network            module 11 d and/or the waveform module 11 a and providing            instructions as to how each thermal waveform is to be            administered to the patient using the treatment module 11 b;        -   ii) selecting one or more thermal waveforms from the            waveform database 11 h and providing instructions as to how            each thermal waveform is to be administered to the patient            using the treatment module 11 b;        -   iii) receiving a prescription from the network module 11 d            and modifying the instructions as to how each thermal            waveform is to be administered to the patient using the            treatment module 11 b;        -   ii) retrieving a prescription from the prescription database            11 i and modifying the instructions as to how each thermal            waveform is to be administered to the patient using the            treatment, module 11 b;    -   h) transmitting the generated prescription to the control module        11 c and/or storing the generated prescription in the        prescription database and/or    -   i) delivering one or more thermal waveform(s) to the vestibular        system and/or the nervous system of the patient by:        -   i) receiving a prescription comprising a set of instructions            for delivering one or more thermal waveforms to the            vestibular system and/or the nervous system of the patient            from the treatment module 11 b and activating the TEDs 13 a,            13 b in accordance with the instructions; or        -   ii) retrieving a prescription comprising a set of            instructions for delivering one or more thermal waveforms to            the vestibular system and/or the nervous system of the            patient from the prescription database 11 i and activating            the TEDs 13 a, 13 b in accordance with the instructions.

Also as noted above with respect to FIG. 1, the vestibular stimulationdevice 1 may further comprise a pair of sensors 14 a, 14 b, wherein oneof the sensors 14 a is operatively connected to the earpiece 12 a thatis configured so as to be insertable into the left ear canal of thepatient, wherein the other sensor 14 b is operatively connected to theearpiece 12 b that is configured so as to be insertable into the rightear canal of the patient and wherein the controller 11 is operativelyconnected to each of the sensors 14 a, 14 b via a wireless connection 17a, 17 b. In some such embodiments, controller 11 (e.g., a controller 11as described above with respect to FIG. 15) is configured such thatcontroller feedback data received from the sensors (e.g., dataassociated with the temperature of the earpiece(s), data associated withthe temperature of the patient's ear canal(s), data associated with therate at which an earpiece is warmed/cooled in response to awarming/cooling stimulus, etc.) is used by the control module 11 c toensure that the appropriate thermal waveform(s) is delivered to thevestibular system and/or the nervous system of the patient (e.g., thecontrol module 11 c may be configured to increase/decrease the magnitudeof TED 13 a activation if/when controller feedback data from the sensor14 b associated with the left earpiece 12 a indicates that thetemperature of the earpiece 12 a is not at the appropriate temperaturegiven the parameters of the prescribed thermal waveform).

As shown in FIG. 19, in some embodiments, the vestibular stimulationdevice comprises a controller 11 and a headset 18. As shown therein, theheadset may comprise a headband 18 h configured to position a firstearpiece 12 a in the left ear canal of a patient and to position asecond earpiece 12 b in the right ear canal of the subject; a first heatsink thermally coupled to the first earpiece 12 a (as shown, the firstheat sink is concealed within a first housing 18 a, the ventilationapertures 18 av of which allow for heat exchange between the first heatsink and the ambient environment), a second heat sink thermally coupledto the second earpiece 12 b (as shown, the first heat sink is concealedwithin a second housing 18 b, the ventilation apertures 18 bv of whichallow for heat exchange between the second heat sink and the ambientenvironment); a first TED thermally coupled between the first earpiece12 a and the first heat sink (as shown, the first TED is concealedwithin the first housing 18 a); a second TED 13 b thermally coupledbetween the second earpiece 12 b and the second heat sink (as shown, thesecond TED 13 b is concealed within the second housing 18 b); a firstsensor operatively connected to the first TED and the controller 11 (asshown, the first sensor is concealed within the first earpiece 12 a; asecond sensor operatively connected to the second TED and the controller11 (as shown, the second sensor is concealed within the second earpiece12 a; a first cushion 18 c connected to the first housing 18 a and asecond cushion 18 d connected to the second housing 18 b. In some suchembodiments, the controller is operatively connected to the first andsecond TEDs by a pair of thermal stimulation leads 16 a, 16 b. In somesuch embodiments, the controller 11 is operatively connected to thefirst and second sensors via a wireless connection (e.g., via aradiofrequency transceiver or a Bluetooth connection). In some suchembodiments, one or both of the first and second cushions 18 c, 18 d isconfigured to be adjustable (e.g., the first cushion 18 c and/or thesecond cushion 18 d may comprise an inner chamber that may beinflated/deflated to adjust the firmness and/or the size of the cushion,thereby allowing a user to adjust the fit of the vestibular stimulationdevice (i.e., to adjust how far the first and/or second earpiece 12 a,12 b inserts into the patient's ear canal by increasing/decreasing theamount of gas/liquid in the inner chamber)).

As discussed above with respect to FIG. 19, in some embodiments of thepresent invention, various components of the vestibular stimulationdevice 1 are concealed within the first and/or second housings 18 a, 18b. FIG. 20 provides an exploded view of a first housing 18 a accordingto some embodiments of the present invention. As shown therein, thefirst housing 18 a may conceal a first TED 13 a; a first sensor 14 a; afirst heat sink 15 a, said first heat sink 15 a comprising a first heatsink base 15 ab, a first heat sink spacer 18 as, a plurality of fins 15af and a plurality of cable apertures 15 ac to provide passageways forone or more wires and/or cables (e.g., one or wires connected to thefirst TED 13 a and/or one or wires connected to the first sensor 14 a),and two heat dissipating fans 19 a, 19 b. The first earpiece 12 a may bethermally connected to the first TED 13 a and the first heat sink 15 aas shown in FIGS. 21A-21B. The first TED 13 a may be positioned on thetop surface 15 as′ of the heat sink spacer 15 as and inside the basecavity 120 a of the first earpiece 12 a and may be adhered to the heatsink 15 a and/or the first earpiece 12 a using a thermally conductiveadhesive (e.g., silver paste). The first sensor 14 a may be positionedinside the tip cavity 121 of the first earpiece 12 a and may beconfigured to provide controller feedback data associated with thetemperature of the first earpiece 12 a to the controller (as discussedabove). Upon activation, the heat dissipating fans 19 a, 19 b mayfacilitate the transfer of heat between the first heat sink 15 a and theambient environment by increasing air flow across the first heat sink 15a. The outer member 18 ao of the first housing 18 a comprisesventilation apertures 18 av to further facilitate the transfer of heatbetween the first heat sink 15 a and the ambient environment (byincreasing the flow of air across the first heat sink 15 a) and a cableaperture 18 ac to provide a passageway for one or more wires and/orcables (e.g., the thermal stimulation lead 16 a and/or one or wiresconnected to the first sensor 14 a). The inner member 18 ai of the firsthousing 18 a comprises an earpiece aperture 18 ae through which thedistal portion of the first earpiece 12 a protrudes. As will beappreciated by one skilled in the art, the second housing 18 b may besimilarly configured.

Physician Control Device

As noted above, the present invention provides a physician controldevice for generating and/or modifying the parameters, indicationsand/or approvals of one of more thermal waveforms; for generating,modifying, updating and/or extending one or more prescriptions and/orfor receiving, analyzing and/or transmitting data.

In some embodiments, the physician control device is configured togenerate a prescription comprising instructions for delivering one ormore thermal waveforms to the vestibular system and/or the nervoussystem of a patient and to transmit the prescription to a vestibularstimulation device (e.g., a vestibular stimulation device of the presentinvention) and/or a patient control device (e.g., a patient controldevice of the present invention).

In some such embodiments, the physician control device comprises,consists essentially of or consists of a treatment module configured togenerate a prescription and a network module configured to transmit theprescription to a vestibular stimulation device and/or a patient controldevice.

A physician control device of the present invention may be any suitablecomputing device/system, including, but not limited to, a desktopcomputer, a laptop computer, a handheld computer, a personal digitalassistant (PDA), and a smart phone.

Any conventional security means may be provided to prevent unauthorizedactivation of the physician control device. For example, the physiciancontrol device may be password protected.

The physician control support device may be configured to receive and/ortransmit and suitable data, including, but not limited to, dataassociated with the parameters, indications and/or approvals of one ormore thermal waveforms, data associated with one or more prescriptions,controller feedback data, data associated with the delivery of one ormore thermal waveforms, data associated with the fit of one or moreearpieces, patient feedback data, physician feedback data and/or patientinformation.

The physician control device may be configured to receive and/ortransmit data from/to various devices, including, but not limited to, avestibular stimulation device, a patient control device, a physiciansupport device, a registry, a TED, a sensor and/or a portable memorydevice (e.g., an SD memory card). In some embodiments, the physiciancontrol device is configured to receive data associated with theparameters, indications and/or approvals of one or more thermalwaveforms (e.g., idealized thermal waveforms) from a physician supportdevice, a registry and/or a portable memory device (e.g., an SD memorycard); to transmit data associated with the parameters, indicationsand/or approvals of one or more thermal waveforms (e.g., idealizedthermal waveforms) to a vestibular stimulation device, a patient controldevice, a registry and/or a portable memory device (e.g., an SD memorycard); to receive one or more prescriptions from a physician supportdevice, a registry and/or a portable memory device (e.g., an SD memorycard); to transmit one or more prescriptions to a vestibular stimulationdevice, a patient control device, a registry and/or a portable memorydevice (e.g., an SD memory card); to receive one or more prescriptionmodifications, updates and/or extensions from a physician supportdevice, a registry and/or a portable memory device (e.g., an SD memorycard); to transmit one or more prescription modifications, updatesand/or extensions to a vestibular stimulation device, a patient controldevice, a registry and/or a portable memory device (e.g., an SD memorycard); to receive data associated with the delivery of one or morethermal waveforms (e.g., idealized thermal waveforms) from a vestibularstimulation device, a patient control device and/or a portable memorydevice (e.g., an SD memory card); to transmit data associated with thedelivery of one or more thermal waveforms (e.g., idealized thermalwaveforms) to a physician support device, a registry and/or a portablememory device (e.g., an SD memory card); to receive patient feedbackdata from a vestibular stimulation device, a patient control deviceand/or a portable memory device (e.g., an SD memory card); to transmitpatient feedback data to a physician support device, a registry and/or aportable memory device (e.g., an SD memory card); to transmit physicianfeedback data to a physician support device, a registry and/or aportable memory device (e.g., an SD memory card); to receive patientinformation from a vestibular stimulation device, a patient controldevice and/or a portable memory device (e.g., an SD memory card) and/orto transmit patient information to a physician support device, aregistry and/or a portable memory device (e.g., an SD memory card).

The physician control device may be configured to receive and/ortransmit data over any suitable wired or wireless communicationschannel, including, but not limited to, a LAN, the Internet, a publictelephone switching network, Bluetooth, WLAN and the like.

In some embodiments, the physician control device comprises memory, aprocessor and a power supply. As will be appreciated by one of skill inthe art, the processor may be any commercially available or custommicroprocessor. Memory can include, but is not limited to, the followingtypes of devices: cache, ROM, PROM, EPROM, EEPROM, flash memory, SRAMand DRAM. The power supply may be an internal power supply (e.g., one ormore rechargeable batteries that may be recharged without first beingremoved from the physician control device).

The physician control device's memory may comprise any suitable softwareand/or data, including, but not limited to, an operating system,applications, data and input/output (I/O) drivers.

As will be appreciated by one of skill in the art, the physician controldevice may use any suitable operating system, including, but not limitedto, OS/2, AIX, OS/390 or System390 from International Business MachinesCorp. (Armonk, N.Y.), Window CE, Windows NT, Windows95, Windows98,Windows2000, Windows 7 or Windows Vista from Microsoft Corp. (Redmond,Wash.), Mac OS from Apple, Inc. (Cupertino, Calif.), Unix, Linux orAndroid.

As will be appreciated by one of skill in the art, the physician controldevice may comprise any suitable application, including, but not limitedto, one or more programs configured to implement one or more of thevarious features of the present invention. For example, the physiciancontrol device may comprise a waveform module that enables a user togenerate and/or modify the parameters, indications and/or approvals ofone or more thermal waveforms; a treatment module that enables a user togenerate, modify, update and/or extend a prescription comprising a setof instructions for delivering one or more thermal waveforms to thevestibular system and/or the nervous system of a patient; a networkmodule configured to receive and/or transmit data; a GUI moduleconfigured to display information and/or accept user input; a feedbackmodule configured to receive, transmit, and/or analyze data associatedwith the delivery of one or more thermal waveforms, data associated withthe fit of one or more earpieces, patient feedback data, physicianfeedback data and/or patient information; an alert generation moduleconfigured to generate one or more alert messages; a tone generationmodule configured to produce one or more audible tones; a visualindicator module configured to produce one or more visual indicatorsand/or a security module configured to prevent unauthorized use of thephysician control device. In some embodiments, two or more of theaforementioned modules are combined to form a single module configuredto carry out the function(s) of each of the individual modules (e.g.,the physician control device may comprise a waveform-treatment modulethat enables a user to generate and/or modify one or more thermalwaveforms and to generate, modify, update and/or extend a prescription).In some embodiments, one of the aforementioned modules is split into twoor more distinct modules (e.g., the physician control device maycomprise a waveform generation module that enables a user to generatethe parameters, indications and/or approvals of one or more thermalwaveforms and a waveform update module that enables a user to modify theparameters, indications and/or approvals of one or more thermalwaveforms). In some embodiments, one or more of the functions describedbelow with respect to one of the modules described below is performed byone of the other modules described below (e.g., the treatment module,rather than the waveform module, may be configured to modify theparameters, indications and/or approvals of one or more thermalwaveforms).

A. Waveform Module

In some embodiments, the physician control device comprises a waveformmodule whereby a user may generate and/or modify the parameters,indications and/or approvals of one or more thermal waveforms.

In some embodiments, the waveform module comprises software that enablesa user to generate and/or modify the parameters of one or more thermalwaveforms by point-to-point design and/or by utilizing mathematicalfunctions. For example, the waveform module may comprise software thatenables a user to generate and/or modify the parameters, indicationsand/or approvals of a thermal waveform by selecting/altering one or moreparameters, including, but not limited to, shape, frequency, amplitudeand duration. In some embodiments, the waveform module enables a user toretrieve/select a thermal waveform from a database and then modify theparameters of that thermal waveform to generate a new thermal waveform.

In some embodiments, the waveform module comprises software that enablesa user to generate and/or modify the parameters, indications and/orapprovals of one or more thermal waveforms using an interactive touchscreen. For example, the waveform module may comprise software thatenables a user to generate the parameters of a thermal waveform bydrawing the desired waveform on an interactive touch screen (asdiscussed above with respect to FIG. 3). Similarly, the waveform modulemay enable a user to modify the parameters of a thermal waveform byhighlighting one or more points on the waveform and moving the point(s)to a new location (e.g., a higher/lower temperature) (as discussed abovewith respect to FIG. 4).

In some embodiments, the waveform module comprises software thatautomatically adjusts the parameters of the thermal waveform(s) createdby a user to account for system limitations. For example, the waveformmodule may comprise software that automatically adjusts the slope of athermal waveform in accordance with the minimum/maximum temperatureand/or the rate of temperature change that is achievable using aparticular combination of earpiece(s), TED(s), etc. That is, thewaveform module may comprise software that prevents a user fromgenerating parameters for a thermal waveform that cannot be deliveredbecause of system limitations.

In some embodiments, the waveform module comprises software that enablesa user to protect one or more thermal waveforms (i.e., to prevent one ormore users from modifying the parameters, indications and/or approvalsof the thermal waveform(s) and/or from deleting the thermal waveform(s)from a waveform database). For example, the waveform module may comprisesoftware that enables a user to protect one or more idealized thermalwaveforms (e.g., by requiring users to enter a specified password priorto modifying and/or deleting the idealized thermal waveform(s)).

In some embodiments, the waveform module comprises software that enablesa user to remove the protected status from one or more thermalwaveforms. For example, the waveform module may comprise software thatenables a user to remove the protected status from one or more idealizedthermal waveforms (e.g., by entering the appropriate password).

In some embodiments, the waveform module is configured to automaticallygenerate and/or modify the parameters, indications and/or approvals ofone or more thermal waveforms (e.g., idealized thermal waveforms) inresponse to data received from one or more devices/modules. For example,the waveform module may be configured to automatically update one ormore thermal waveforms responsive to data received from one or more TEDsand/or one or more sensors.

The waveform module may be configured to retrieve the parameters,indications and/or approvals of one or more thermal waveforms from anysuitable database, including, but not limited to, a waveform databaseresiding in a vestibular stimulation device, a waveform databaseresiding in a patient control device, a waveform database residing inthe physician control device, a waveform database residing in aphysician support device, a waveform database residing in a registryand/or a waveform database residing in a portable memory device (e.g.,an SD memory card).

Waveform parameters, indications and/or approvals generated and/ormodified by the waveform module may be stored in a database. In someembodiments, the generated/modified parameters, indications and/orapprovals are stored in a waveform database comprising data associatedwith the parameters, indications and/or approvals of one or more thermalwaveforms (e.g., idealized thermal waveforms). For example, thegenerated/modified waveform parameters, indications and/or approvals maybe stored in a waveform database residing in a vestibular stimulationdevice, a waveform database residing in a patient control device, awaveform database residing in the physician control device, a waveformdatabase residing in a physician support device, a waveform databaseresiding in a registry and/or a waveform database residing in a portablememory device (e.g., an SD memory card).

B. Treatment Module

In some embodiments, the physician control device comprises a treatmentmodule whereby a user (e.g., a physician) may generate, modify, updateand/or extend a prescription. For example, the treatment module mayenable a user to generate, modify, update and/or extend a prescriptioncomprising a set of instructions for delivering one or more thermalwaveforms to the vestibular system and/or the nervous system of apatient.

In some embodiments, the treatment module comprises software thatenables a user to select one or more thermal waveforms from a database(e.g., an idealized thermal waveform from an idealized waveformdatabase) and to provide instructions as to when/how each of thosewaveforms should be administered. For example, a treatment module maycomprise software that enables a user to provide instructions as to howlong a treatment schedule is to last (as discussed above with respect toFIG. 5), to provide instructions as to how many treatments may beadministered each day (as discussed above with respect to FIG. 5), toprovide instructions as to how often each thermal waveform is to beadministered (as discussed above with respect to FIG. 6), to provideinstructions as to what time(s) of day each thermal waveform is to beadministered (as discussed above with respect to FIGS. 6 and 9), toselect one or more idealized thermal waveforms from a database (asdiscussed above with respect to FIG. 7), to provide instructionsregarding whether each of the selected thermal waveforms is to bedelivered to the right and/or left ear canal of a patient (as discussedabove with respect to FIG. 8), etc.

In some embodiments, the treatment module comprises software thatenables a user to modify, update and/or extend a prescription bychanging one or more parameters of the prescription (as discussed abovewith respect to FIG. 10), including, but not limited to, which thermalwaveform(s) are delivered, frequency with which the thermal waveform(s)is/are delivered, and the expiration date of the prescription. Anysuitable prescription may be modified, updated and/or extended,including, but not limited to, prescriptions stored in a prescriptiondatabase (e.g., a prescription database residing in a vestibularstimulation device, in a patient control device, in the physiciancontrol device, in a physician support device or in a portable memorydevice, such as a portable SD memory card).

The treatment module may be configured to retrieve/select thermalwaveforms from any suitable database, including, but not limited to, awaveform database residing in a vestibular stimulation device, awaveform database residing in a patient control device, a waveformdatabase residing in the physician control device, a waveform databaseresiding in a physician support device, a waveform database residing ina registry and/or a waveform database residing in a portable memorydevice (e.g., an SD memory card).

The treatment module may be configured to retrieve prescriptions fromany suitable database, including, but not limited to, a prescriptiondatabase residing in a vestibular stimulation device, a prescriptiondatabase residing in a patient control device, a prescription databaseresiding in the physician control device, a prescription databaseresiding in a physician support device, a prescription database residingin a registry and/or a prescription database residing in a portablememory device (e.g., an SD memory card).

Prescriptions generated, modified, updated and/or extended by thetreatment module may be added to a database comprising one or moreprescriptions. For example, the prescriptions may be stored in aprescription database residing in a vestibular stimulation device, aprescription database residing in a patient control device, aprescription database residing in the physician control device, aprescription database residing in a physician support device, aprescription database residing in a registry and/or a prescriptiondatabase residing in a portable memory device.

C. Network Module

In some embodiments, the physician control device comprises a networkmodule configured to receive, retrieve and/or transmit data.

The network module may be configured to receive, retrieve and/ortransmit data from/to any suitable device/module/database, including,but not limited to, other modules residing in the physician controldevice, databases residing in the physician control device, a vestibularstimulation device, a patient control device, a physician supportdevice, a registry, a TED, a sensor and a portable memory device (e.g.,an SD memory card).

The network module may be configured to receive, retrieve and/ortransmit data over any suitable wired or wireless communicationschannel, including, but not limited to, a LAN, the Internet, a publictelephone switching network, Bluetooth, WLAN and the like.

The network module may be configured to receive, retrieve and/ortransmit any suitable data, including, but not limited to, dataassociated with the parameters, indications and/or approvals of one ormore thermal waveforms, one or more prescriptions, controller feedbackdata, data associated with the delivery of one or more thermalwaveforms, data associated with the fit of one or more earpieces,patient feedback data, physician feedback data and/or patientinformation.

In some embodiments, the network module is configured to receive and/orretrieve data associated with the parameters, indications and/orapprovals of one or more thermal waveforms from a waveformmodule/database residing in the physician control device, from avestibular stimulation device, from a patient control device, from aphysician support device, from a registry and/or from a portable memorydevice.

In some embodiments, the network module is configured to receive and/orretrieve one or more prescriptions from a treatment module residing inthe physician control device, from a prescription database residing inthe physician control device, from a vestibular stimulation device, froma patient control device, from a physician support device, from aregistry and/or from a portable memory device.

In some embodiments, the network module is configured to receive and/orretrieve controller feedback data, data associated with the delivery ofone or more thermal waveforms and/or data associated with the fit of oneor more earpieces from a feedback module/database residing in thephysician control device, from a vestibular stimulation device and/orfrom a patient control device.

In some embodiments, the network module is configured to receive and/orretrieve patient feedback data, physician feedback data and/or patientinformation from a feedback module/database residing in the physiciancontrol device, from a GUI module residing in the physician controldevice, from a patient information database residing in the physiciancontrol device, from a vestibular stimulation device, from a patientcontrol device, from a physician support device, from a registry and/orfrom a portable memory device.

In some embodiments, the network module is configured to transmit dataassociated with the parameters, indications and/or approvals of one ormore thermal waveforms to a waveform module/database residing in thephysician control device, to a treatment module residing in thephysician control device, to a vestibular stimulation device, to apatient control device, to a physician support device, to a registryand/or to a portable memory device.

In some embodiments, the network module is configured to transmit one ormore prescriptions to a treatment module residing in the physiciancontrol device, to a prescription database residing in the physiciancontrol device, to a vestibular stimulation device, to a patient controldevice, to a physician support device, to a registry and/or to aportable memory device.

In some embodiments, the network module is configured to transmitcontroller feedback data, data associated with the delivery of one ormore thermal waveforms and/or data associated with the fit of one ormore earpieces to a feedback module/database residing in the physiciancontrol device, to a vestibular stimulation device, to a patient controldevice, to a physician support device, to a registry and/or to aportable memory device.

In some embodiments, the network module is configured to transmitpatient feedback data, physician feedback data and/or patientinformation to a feedback module/database residing in the physiciancontrol device, to a patient information database residing in thephysician control device, to a vestibular stimulation device, to apatient control device, to a physician support device, to a registryand/or to a portable memory device.

In some embodiments, the network module is configured to access adatabase comprising data associated with the parameters, indicationsand/or approvals of one or more thermal waveforms (e.g., idealizedthermal waveforms). For example, the network module maybe configured toaccess a waveform database residing in a vestibular stimulation device,a waveform database residing in a patient control device, a waveformdatabase residing in the physician control device, a waveform databaseresiding in a physician support device, a waveform database residing ina registry and/or a waveform database residing in a portable memorydevice.

In some embodiments, the network module is configured to access adatabase comprising one or more prescriptions. For example, the networkmodule maybe configured to access a prescription database residing in avestibular stimulation device, a prescription database residing in apatient control device, a prescription database residing in thephysician control device, a prescription database residing in aphysician support device, a prescription database residing in a registryand/or a prescription database residing in a portable memory device.

In some embodiments, the network module is configured to access adatabase comprising controller feedback data, data associated with thedelivery of one or more thermal waveforms, data associated with the fitof one or more earpieces, patient feedback data and/or physicianfeedback data. For example, the network module maybe configured toaccess a feedback database residing in a vestibular stimulation device,a feedback database residing in a patient control device, a feedbackdatabase residing in the physician control device, a feedback databaseresiding in a physician support device, a feedback database residing ina registry and/or a feedback database residing in a portable memorydevice.

In some embodiments, the network module is configured to access adatabase comprising patient information. For example, the network modulemaybe configured to access a patient information database residing in avestibular stimulation device, a patient information database residingin a patient control device, a patient information database residing inthe physician control device, a patient information database residing ina physician support device, a patient information database residing in aregistry and/or a patient information database residing in a portablememory device.

E. Graphical User Interface Module

In some embodiments, the physician control device comprises a GUI moduleconfigured to display information and/or to accept user input. Anysuitable GUI may be used, including, but not limited to, a keyboard, amouse, an LCD display with one or more associated entry keys and aninteractive touch screen. For example, the GUI may comprise a staticpressure touch-sensitive display, a capacitive touch-sensitive display,a resistive touch-sensitive display, an electrostatic capacity proximitysensor, a magnetic proximity sensor and/or an infrared proximity sensor.See, e.g., U.S. Patent Publication Nos. 2011/0271222, 2011/0273575,2011/0275414 and 2011/0275416.

The GUI module may be configured to display any suitable information,including, but not limited to, data associated with the delivery of oneor more thermal waveforms. For example, the GUI module may be configuredto display the current date and/or time (as discussed above with respectto FIG. 10); one or more target temperatures (as discussed above withrespect to FIG. 11); the number of treatment sessions that have beenadministered for a prescription; the number of treatment sessionsremaining in a prescription; the amount of time remaining until aprescription must be renewed/updated; the amount of remaining batterylife, an alert message (e.g., a reminder to a physician that he/sheneeds to modify, update and/or extend a prescription); the targettime/temperature parameters of one or more prescribed thermalwaveform(s) (as discussed above with respect to FIG. 11); the precisetime/temperature parameters of the thermal waveform(s) delivered to apatient; the date/time of delivery of the thermal waveform(s) deliveredto a patient; the temperature(s) of a patient's ear canal(s) at varioustime points before, during and/or after delivery of the thermalwaveform(s); the temperature(s) of a patient's inner ear(s) at varioustime points before, during and/or after delivery of the thermalwaveform(s); the fit of the earpiece(s) at various time points before,during and/or after delivery of the thermal waveform(s); an estimate ofthe thermal contact between the earpiece(s) and the patient's earcanal(s) at various time points before, during and/or after delivery ofthe thermal waveform(s); patient-specific time constants (e.g., a timeconstant associated with the transduction of heat from a patient's earcanal to the inner ear); reaction time (i.e., how long it took for apatient to react to one or more thermal waveforms); the effectiveness ofone or more thermal waveforms (i.e., whether and to what extent symptomswere relieved, whether the thermal waveform(s) enhanced theeffectiveness of another agent/therapy, etc.); the stability of atreatment (i.e., how long the effects of the treatment lasted); theinstability of a treatment (i.e., which symptom(s) returned and when didit/they return); the presence or absence of comorbid disorders, injuriesand/or diseases; disorder, injury and/or disease modulation(s) and/ormodification(s) that occurred as a result of treatment; the cognitiveeffect(s) of one or more thermal waveforms; patient compliance (e.g.,whether a patient initiated delivery at the prescribed time, whether apatient completed the prescribed treatment session, whether theearpiece(s) remained properly fitted in a patient's ear canal(s) for theduration of the treatment session, etc.); the mood of a patient atvarious time points before, during and/or after delivery of one or morethermal waveforms (e.g., videos/images of a patient that may be used toassess mood); objectives measures of efficacy (e.g., nystamography data,EEG data, MRI data, heart rate data, blood pressure data); subjectivemeasures of efficacy (e.g., a patient-reported pain score); bloodchemistry data (e.g., blood A1c levels, blood glucose levels and bloodcortisol levels); saliva chemistry data (e.g., saliva cortisol levels);urine chemistry data (e.g., urine cortisol levels)), comments a patientmade about his/her treatment session(s) (e.g., comments made to aphysician, submitted in response to an automated survey and/or recordedin a treatment diary); the impedance between an earpiece inserted intothe ear canal of a patient and an electrode affixed to a second locationon/in said patient's body (e.g., an electrode placed in or adjacent tothe patient's other ear canal); the rate at which a patient's inner earcools in response to a cooling stimulus (e.g., data from a temperaturesensor, such as thermistor, that monitors how quickly the inner earcools in response to a cooling waveform); the rate at which a patient'sinner ear warms in response to a warming stimulus (e.g., data from atemperature sensor, such as thermistor, that monitors how quickly theinner ear warms in response to a warming waveform) and/or patientcomments regarding the subjective fit of his/her earpiece(s).

The GUI module may be configured to accept any suitable user input,including, but not limited to, instructions for generating and/ormodifying the parameters, indications and/or approvals of a thermalwaveforms; instructions for generating, modifying, updating and/orextending a prescription; physician feedback and/or patient information.For example, the GUI module may be configured to accept a physiciancomments regarding the effectiveness of a particular combination ofthermal waveforms.

F. Feedback Module

In some embodiments, the physician control device comprises a feedbackmodule configured to receive, transmit and/or analyze data.

The feedback module may be configured to receive and/or transmit datafrom/to any suitable device/module/database, including, but not limitedto, other modules residing in the physician control device, databasesresiding in the physician control device, a vestibular stimulationdevice, a patient control device, a physician support device, aregistry, a TED, a sensor and a portable memory device (e.g., an SDmemory card).

The feedback module may be configured to receive and/or transmit dataover any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like.

The feedback module may be configured to receive, transmit and/oranalyze any suitable data, including, but not limited to, controllerfeedback data, data associated with the delivery of one or more thermalwaveforms, data associated with the fit of one or more earpieces,patient feedback data, physician feedback data and/or patientinformation.

In some embodiments, the feedback module is configured to receive and/oranalyze data associated with the delivery of one or more thermalwaveforms and/or data associated with the fit of one or more earpiecesfrom a feedback database residing in the physician control device, fromone or more vestibular stimulation devices and/or from one or morepatient control devices. For example, the feedback module may beconfigured to analyze the accuracy with which one or more prescribedwaveforms was delivered to a patient, the fit of an earpiece based uponthe rate at which the temperature of the earpiece changes in response toa cooling/warming waveform, the slew rate associated with one or moreTEDs, the impedance between an earpiece positioned in the left ear canalof a patient and an earpiece positioned in the right ear canal of apatient, the impedance between an earpiece positioned in the ear canalof a patient and an electrode affixed to a second location on/in thepatient's body, etc.

In some embodiments, the feedback module is configured to receive and/oranalyze patient feedback data, physician feedback data and/or patientinformation from a GUI module residing in the physician control device,from a feedback database residing in the physician control device, froma patient information database residing in the physician control device,from a vestibular stimulation device, from a patient control device,from a physician support device and/or from a portable memory device.For example, the feedback module may be configured to analyze theeffectiveness of a given thermal waveform or combination of thermalwaveforms (e.g., by analyzing pain scores entered before, during andafter a treatment session), the effect(s) of one or more waveformmodifications (e.g., by analyzing whether/how much a given waveformmodification changed the effectiveness of a thermal waveform in treatinga disease/disorder), etc.

In some embodiments, the feedback module is configured to transmit dataassociated with the delivery of one or more thermal waveforms, dataassociated with the fit of one or more earpieces, patient feedback data,physician feedback data, patient information and/or data associated withits analysis to a feedback database residing in the physician controldevice, to a patient information database residing in the physiciancontrol device, to a physician support device, to a registry and/or to aportable memory device (e.g., an SD memory card).

G. Alert Generation Module

In some embodiments, the physician control device comprises an alertgeneration module configured to generate one or more alert t messages.

The alert generation module may be configured to generate any suitablealert message, including, but not limited to, a reminder that a patientis due for a prescription refill; an alert indicating that one or moreidealized thermal waveforms has been modified; an alert indicating thata given modification is likely to increase/decrease the effectiveness ofa given thermal waveform and/or an alert indicating that a given thermalwaveform, class of thermal waveforms or combination of thermal waveformshas been identified as being indicated and/or approved for use in thetreatment of a disease/disorder and a warning that the physician controldevice's internal power supply is low.

In some embodiments, the alert generation module is configured tocommunicate with various devices/modules, including, but not limited to,a vestibular stimulation device, a patient control device, a physiciansupport device, a registry, a TED, a sensor, a portable memory device(e.g., an SD memory card) and other modules of the physician controldevice. For example, the alert generation module may be configured toprovide instructions to the GUI module and/or the tone generation modulefor displaying one or more alert messages and/or for generation anaudible tone to alert a user of the presence of the one or more alertmessages. The graphical user interface module may be configured todisplay the one or more alert messages immediately upon generation orupon interaction with a user (e.g., an alert notification icon may begenerated, with the alert message being displayed only after the userindicates that he/she wishes to view the message).

H. Tone Generation Module

In some embodiments, the physician control device comprises a tonegeneration module configured to produce audible tones. In some suchembodiments, the tone generation module comprises a piezo buzzer.Audible tones may be produced to alert a user to variouscircumstances/events, including, but not limited to, the existence of anunread/unviewed alert message. Audible tones may be generated repeatedlyin response to a single circumstance/event (e.g., an audible tone may begenerated repeatedly until the user views/reads the message) and maybecome progressively louder and/or more frequent with time.

I. Visual Indicator Module

In some embodiments, the physician control device comprises a visualindicator module configured to notify a user of the existence of anunread/unviewed alert message. In some such embodiments, the visualindicator module comprises an LED indicator light. The visual indicatormodule may be activated repeatedly in response to a single alert message(e.g., an LED light may be illuminated repeatedly until the userviews/reads the message) or may remain activated until the userviews/reads the message.

J. Security Module

In some embodiments, the physician control device comprises a securitymodule configured to prevent unauthorized use of the physician controldevice (i.e., to prevent unauthorized persons from using the physiciancontrol device, to prevent authorized persons from using the physiciancontrol device in an unauthorized manner, etc.).

The security module may be configured to prevent unauthorized use of thephysician control device using any suitable means of security,including, but not limited to, password protection and data encryption.For example, the security module may be configured such that a user isrequired to input a designated password prior to generating and/ormodifying a thermal waveform; generating, modifying, updating and/orextending a prescription; entering/viewing patient feedback data;entering/viewing physician feedback data and/or entering/viewing patientinformation (as discussed above with respect to FIG. 12).

As will be appreciated by one of skill in the art, the physician controldevice may comprise any suitable data, including, but not limited to,static and/or dynamic data used by the operating system, applications,I/O device drivers and other software components, controller feedbackdata, data associated with the parameters, indications and/or approvalsof one or more thermal waveforms (e.g., idealized thermal waveforms),data associated with one or more prescriptions, data associated with thedelivery of one or more thermal waveforms, data associated with the fitof one or more earpieces, patient feedback data, physician feedback dataand patient information. For example, the physician control device maycomprise a waveform database comprising data associated with one or moreidealized thermal waveforms; a prescription database comprising dataassociated with one or more prescriptions; a feedback databasecomprising controller feedback data, data associated with the deliveryof one or more thermal waveforms to the vestibular system and/or thenervous system of a patient, patient feedback data and physicianfeedback data and/or a patient history database comprising dataassociated with one or more patients. In some embodiments, two or moreof the aforementioned databases are combined to form a single databasecomprising data from each of the individual databases (e.g., thephysician control device may comprise a feedback-history databasecomprising data associated with the delivery of one or more thermalwaveforms and patient information). In some embodiments, one of theaforementioned databases is split into two or more distinct databases(e.g., the physician control device may comprise a delivery feedbackdatabase comprising data associated with the specific parameters of thethermal waveform(s) delivered to a patient, a patient feedback databasecomprising patient feedback data and a physician feedback databasecomprising physician feedback data). In some embodiments, one or more ofthe data types described below with respect to one of the databasesdescribed below is stored in one of the other databases described below(e.g., the patient information database, rather than the feedbackdatabase, may be configured to receive/store patient feedback data). Insome embodiments, data is transmitted, received and/or stored in acontrolled format (e.g., in a standardized format using forms/programssupplied by a physician support device or a registry). The physiciancontrol device may be configured to transmit, receive and store data ina manner that ensures compliance with any and all applicable laws and/orregulations (e.g., the Health Insurance Portability and AccountabilityAct of 1996 (P.L. 104-191; “HIPAA”)).

A. Waveform Database

In some embodiments, the physician control device comprises a waveformdatabase configured to receive, store and/or transmit data associatedwith the parameters, indications and/or approvals of one or more thermalwaveforms (e.g, one or more idealized thermal waveforms). In some suchembodiments, the waveform database is configured such that one or moreof the thermal waveforms stored therein is/are protected (e.g., usersmay be prevented from modifying and/or deleting the idealized thermalwaveform(s) stored in the waveform database).

The waveform database may comprise any suitable type of memoryincluding, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flashmemory, SRAM and DRAM. In some embodiments, the waveform databasecomprises a portable memory device, such as an SD memory card or a USBmemory stick. For example, the waveform database may comprise an SDmemory card interface and one or more prescriptions may be stored on aportable SD memory card.

The waveform database may be configured to receive and/or transmit datafrom/to any suitable device/module/database, including, but not limitedto, modules residing in the physician control device, a vestibularstimulation device, a patient control device, a physician supportdevice, a registry, a TED, a sensor and a portable memory device (e.g.,an SD memory card).

The waveform database may be configured to receive and/or transmit dataover any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like.

B. Prescription Database

In some embodiments, the physician control device comprises aprescription database configured to receive, transmit and/or store oneor more prescriptions, wherein each prescription comprising a set ofinstructions for delivering one or more thermal waveforms to thevestibular system and/or the nervous system of a patient.

The prescription database may comprise any suitable type of memoryincluding, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flashmemory, SRAM and DRAM. In some embodiments, the prescription databasecomprises a portable memory device, such as an SD memory card or a USBmemory stick. For example, the prescription database may comprise an SDmemory card interface and one or more prescriptions may be stored on aportable SD memory card.

The prescription database may be configured to receive and/or transmitdata from/to any suitable device/module/database, including, but notlimited to, modules residing in the physician control device, avestibular stimulation device, a patient control device, a physiciansupport device, a registry, a TED, a sensor and a portable memory device(e.g., an SD memory card).

The prescription database may be configured to receive and/or transmitdata over any suitable wired or wireless communications channel,including, but not limited to, a LAN, the Internet, a public telephoneswitching network, Bluetooth, WLAN and the like.

C. Feedback Database

In some embodiments, the physician control device comprises a feedbackdatabase configured to receive, transmit and/or store feedback data.

The feedback database may comprise any suitable type of memoryincluding, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flashmemory, SRAM and DRAM. In some embodiments, the feedback databasecomprises a portable memory device, such as an SD memory card or a USBmemory stick. For example, the feedback database may comprise an SDmemory card interface and one or more prescriptions may be stored on aportable SD memory card.

The feedback database may be configured to receive and/or transmitfeedback data from/to any suitable device/module/database, including,but not limited to, modules residing in the physician control device, avestibular stimulation device, a patient control device, a physiciansupport device, a registry, a TED, a sensor and a portable memory device(e.g., an SD memory card).

The feedback database may be configured to receive and/or transmit dataover any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like.

Feedback data may comprise any suitable data, including, but not limitedto, controller feedback data, data associated with the delivery of oneor more thermal waveforms, data associated with the fit of one or moreearpieces, patient feedback data, physician feedback data and/or patientinformation. For example, the feedback database may comprise a log filedetailing the target time/temperature parameters of one or moreprescribed thermal waveform(s); the time/temperature parameters of thethermal waveform(s) delivered to a patient; the date/time of delivery ofthe thermal waveform(s) delivered to a patient; the temperature(s) of apatient's ear canal(s) at various time points before, during and/orafter delivery of one or more thermal waveforms; the temperature(s) of apatient's inner ear(s) at various time points before, during and/orafter delivery of one or more thermal waveforms; the fit of one or moreearpieces at various time points before, during and/or after delivery ofone or more thermal waveforms; an estimate of the thermal contactbetween one or more earpieces and a patient's ear canal(s) at varioustime points before, during and/or after delivery of one or more thermalwaveforms; patient-specific time constants (e.g., a time constantassociated with the transduction of heat from a patient's ear canal tothe inner ear); a patient's reaction time (i.e., how long it took for apatient to react to one or more thermal waveforms); effectiveness of oneor more thermal waveforms (i.e., whether and to what extent symptomswere relieved, whether the thermal waveform(s) enhanced theeffectiveness of another agent/therapy, etc.); stability of a treatment(i.e., how long the effects of a treatment lasted); instability of atreatment (i.e., which symptom(s) returned and when did it/they return);the presence or absence of comorbid disorders, injuries and/or diseases;disorder, injury and/or disease modulation(s) and/or modification(s)that occurred as a result of treatment; the cognitive effect(s) of oneor more thermal waveforms; patient compliance (e.g., whether a patientinitiated delivery at the prescribed time, whether a patient completedthe prescribed treatment session, whether the earpiece(s) remainedproperly fitted in a patient's ear canal(s) for the duration of thetreatment session, etc.); the mood of a patient at various time pointsbefore, during and/or after delivery of one or more thermal waveforms(e.g., videos/images of a patient that may be used to assess mood);objectives measures of efficacy (e.g., nystamography data, EEG data, MRIdata, heart rate data, blood pressure data); subjective measures ofefficacy (e.g., a patient-reported pain score); blood chemistry data(e.g., blood A1c levels, blood glucose levels and blood cortisollevels); saliva chemistry data (e.g., saliva cortisol levels); urinechemistry data (e.g., urine cortisol levels)); comments a patient madeabout his/her treatment session(s) (e.g., comments made to a physician,submitted in response to an automated survey and/or recorded in atreatment diary); the impedance between an earpiece inserted into theear canal of a patient and an electrode affixed to a second locationon/in said patient's body (e.g., an electrode placed in or adjacent tothe patient's other ear canal); the rate at which an earpiece is cooledin response to a cooling stimulus (e.g., data from a temperature sensor,such as thermistor, that monitors how quickly the earpiece cools inresponse to a cooling waveform); the rate at which an earpiece is warmedin response to a warming stimulus (e.g., data from a temperature sensor,such as a thermistor, that monitors how quickly the earpiece warms inresponse to a warming waveform); the rate at which a patient's ear canaland/or inner ear cooled in response to a cooling stimulus (e.g., datafrom a temperature sensor, such as thermistor, that monitors how quicklythe ear canal and/or the inner ear cools in response to a coolingwaveform); the rate at which a patient's ear canal and/or inner earwarmed in response to a warming stimulus (e.g., data from a temperaturesensor, such as a thermistor, that monitors how quickly the ear canaland/or the inner ear warms in response to a warming waveform); patientcomments regarding the subjective fit of one or more earpieces;physician comments regarding the effectiveness of one or more thermalwaveforms and/or physician comments regarding the effect(s) of one ormore waveform modifications.

D. Patient History Database

In some embodiments, the physician control device comprises a patienthistory database configured to receive, transmit and/or store patientinformation.

The patient history database may comprise any suitable type of memoryincluding, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flashmemory, SRAM and DRAM. In some embodiments, the patient history databasecomprises a portable memory device, such as an SD memory card or a USBmemory stick. For example, the patient history database may comprise anSD memory card interface and one or more prescriptions may be stored ona portable SD memory card.

The patient history database may be configured to receive and/ortransmit data from/to any suitable device/module/database, including,but not limited to, modules residing in the physician control device, avestibular stimulation device, a patient control device, a physiciansupport device, a registry, a TED, a sensor and a portable memory device(e.g., an SD memory card).

The patient history database may be configured to receive and/ortransmit data over any suitable wired or wireless communicationschannel, including, but not limited to, a LAN, the Internet, a publictelephone switching network, Bluetooth, WLAN and the like.

Patient information may comprise any suitable information that isassociated with a patient, including, but not limited to, the patient'smedical history, the patient's current symptoms (if any), the patient'spresent diagnosis (if any), the patient's current prescriptions (if any)and data associated with the delivery, of one or more thermal waveformsto the vestibular system and/or the nervous system of the patient.

As will be appreciated by one of skill in the art, the physician controldevice may comprise any I/O device drivers, including, but not limitedto, software routines accessed through the operating system by theapplications to communicate with devices such as I/O ports, memorycomponents, vestibular stimulation devices, patient control devicesand/or physician support devices.

As will be appreciated by one of skill in the art, the physician controldevice may be configured (e.g., with computer instructions (i.e.,software)) to operate in a plurality of distinct modes. In each mode,the physician control device may be configured to permit access to somefunctionalities/modules and to prevent access to otherfunctionalities/modules. For example, the physician control device maybe configured to operate in a physician mode, wherein the user isallowed to perform physician-oriented tasks, such as generating,modifying, updating and/or extending a prescription comprising a set ofinstructions for delivering one or more thermal waveforms to thevestibular system and/or the nervous system of a patient, but isprevented from accessing other functionalities/modules (e.g., the usermay be prevented from generating and/or modifying one or more thermalwaveforms). Likewise, the physician control device may be configured tooperate in a researcher mode, wherein the user is allowed to performresearcher-oriented tasks, such as generating and/or modifying one ormore idealized thermal waveforms, but is prevented from accessing otherfunctionalities/modules (e.g., the user may be prevented from modifyingthe underlying operational parameters of the physician control device).Similarly, the physician control device may be configured to operate inan engineer mode, wherein the user is allowed to access all of thephysician control device's functionalities/modules. Each mode may beprotected via a unique security measure (e.g., the physician controldevice may be configured such that each mode is protected by a uniquepassword).

As shown in FIGS. 22-24, in some embodiments of the present invention,the physician control device 2 comprises memory 20, a processor 21 and apower supply 22 (e.g., an internal power supply), wherein memory 20 isrepresentative of the overall hierarchy of memory devices containingsoftware and data used to implement the functionality of the physiciancontrol device 2 and wherein the processor 21 communicates with thememory 20 via an address/data bus 200. In particular embodiments, memory20 comprises an operating system 20 a, applications 20 b (e.g., awaveform module 2 a configured to generate and/or modify the parameters,indications and/or approvals of one or more thermal waveforms; atreatment module 2 b configured to generate, modify, update and/orextend a prescription comprising a set of instructions for deliveringone or more thermal waveforms to the vestibular system and/or thenervous system of a patient; a network module 2 d configured to receiveand/or transmit data, a GUI module 2 e configured to display informationand/or accept user input and/or a feedback module 2 f configured toreceive, transmit, and/or analyze data), data 20 c (e.g., a waveformdatabase 2 h comprising data associated with the parameters, indicationsand/or approvals of one or more thermal waveforms; a prescriptiondatabase 2 i comprising at least one prescription comprising a set ofinstructions for delivering one or more thermal waveforms to thevestibular system and/or the nervous system of a patient; a feedbackdatabase 2 j comprising data associated with the delivery of one or morethermal waveforms and/or a patient history database 2 k comprisingpatient information) and I/O drivers 20 d. In some such embodiments,data 20 c comprises one or more databases stored on a portable memorydevice. For example, data 20 c may comprise an SD memory card interfaceand a portable SD memory card comprising a waveform database 2 h, aprescription database 2 i, a feedback database 2 j and/or a patienthistory database 2 k.

In some embodiments, the network module 2 d is configured to receivedata associated with the parameters, indications and/or approvals of oneor more thermal waveforms from the waveform module 2 a, a patientcontrol device, a physician support device, a registry and/or a portablememory device (e.g., an SD memory card) and to transmit the data to thewaveform database 2 h for storage. In some such embodiments, the data isstored on an SD memory card inserted into an SD memory card interface.

In some embodiments, the network module 2 d is configured to retrievedata associated with the parameters, indications and/or approvals of oneor more thermal waveforms from the waveform database 2 h, a physiciansupport device, a registry and/or a portable memory device (e.g., an SDmemory card) and to transmit the data to the waveform module 2 a, thetreatment module 2 b, a vestibular stimulation device, a patient controldevice and/or a physician support device.

In some embodiments, the network module 2 d is configured to receive oneor more prescriptions from the treatment module 2 b, a patient controldevice, a physician support device, a registry and/or a portable memorydevice (e.g., an SD memory card) and to transmit the prescription(s) tothe prescription database 2 i for storage. In some such embodiments, theprescription(s) is/are stored on an SD memory card inserted into an SDmemory card interface.

In some embodiments, the network module 2 d is configured to retrieveone or more prescriptions from the prescription database 2 i, aphysician support device, a registry and/or a portable memory device(e.g., an SD memory card) and to transmit the prescription(s) to thetreatment module 2 b, a vestibular stimulation device, a patient controldevice and/or a physician support device.

In some embodiments, the network module 2 d is configured to receivecontroller feedback data, data associated with the delivery of one ormore thermal waveforms, data associated with the fit of one or moreearpieces, patient feedback data and/or physician feedback data from avestibular stimulation device, a patient control device and/or aportable memory device (e.g., an SD memory card) and to transmit thatdata to the feedback database 2 j for storage. In some such embodiments,the data is stored on an SD memory card inserted into an SD memory cardinterface.

In some embodiments, the network module 2 d is configured to receivephysician feedback data from the GUI module 2 e and to transmit thatdata to the feedback database 2 j for storage. In some such embodiments,the patient information is stored on an SD memory card inserted into anSD memory card interface.

In some embodiments, the network module 2 d is configured to retrievecontroller feedback data, data associated with the delivery of one ormore thermal waveforms, data associated with the fit of one or moreearpieces and/or physician feedback data from the feedback database 2 jand to transmit the data to the feedback module 2 f, a physician supportdevice, a registry and/or a portable memory device (e.g., an SD memorycard).

In some embodiments, the network module 2 d is configured to receivepatient information from the GUI module 2 e, a vestibular stimulationdevice, a patient control device, a physician support device, a registryand/or a portable memory device (e.g., an SD memory card) and totransmit that data to the patient history database 2 k for storage. Insome such embodiments, the patient information is stored on an SD memorycard inserted into an SD memory card interface.

In some embodiments, the network module 2 d is configured to retrievepatient information from the patient history database 2 k and totransmit the patient information to a physician support device, aregistry and/or a portable memory device (e.g., an SD memory card).

Patient Control Device

As noted above, the present invention provides a patient control devicefor receiving, analyzing and/or transmitting data.

In some embodiments, the patient control device is configured to receivea prescription comprising instructions for delivering one or morethermal waveforms to the vestibular system and/or the nervous system ofa patient from a physician control device and to transmit theprescription to a vestibular stimulation device (e.g., a vestibularstimulation device of the present invention).

In some embodiments, the patient control device comprises, consistsessentially of or consists of a network module, a feedback module, aprescription database and a feedback database. In some such embodiments,the network module is configured to receive one or more prescriptionsfrom a physician control device, to transmit the prescription(s) to avestibular stimulation device, to receive feedback data from thevestibular stimulation device and to transmit the feedback data to thephysician control device. In some such embodiments, the prescriptiondatabase comprises one or more prescriptions (e.g., one or moreprescriptions received from a physician control device), and thefeedback database comprises data associated with the delivery of one ormore thermal waveforms, data associated with the fit or one or moreearpieces and/or patient feedback data.

A patient control device of the present invention may be any suitablecomputing device/system, including, but not limited to, a desktopcomputer, a laptop computer, a handheld computer, a personal digitalassistant (PDA), and a smart phone.

Any conventional security means may be provided to prevent unauthorizedactivation of the patient control device. For example, the patientcontrol device may be password protected.

The patient control support device may be configured to receive and/ortransmit and suitable data, including, but not limited to, dataassociated with the parameters, indications and/or approvals of one ormore thermal waveforms, data associated with one or more prescriptions,controller feedback data, data associated with the delivery of one ormore thermal waveforms, data associated with the fit of one or moreearpieces, patient feedback data and/or patient information.

The patient control device may be configured to receive and/or transmitdata from/to various devices, including, but not limited to, avestibular stimulation device, a physician control device, a physiciansupport device, a TED, a sensor and/or a portable memory device (e.g.,an SD memory card). In some embodiments, the patient control device isconfigured to receive data associated with the parameters, indicationsand/or approvals of one or more thermal waveforms (e.g., idealizedthermal waveforms) from a physician control device, a physician supportdevice, a registry and/or a portable memory device (e.g., an SD memorycard); to transmit data associated with the parameters, indicationsand/or approvals of one or more thermal waveforms (e.g., idealizedthermal waveforms) to a vestibular stimulation device and/or a portablememory device (e.g., an SD memory card); to receive one or moreprescriptions from a physician control device, a physician supportdevice, a registry and/or a portable memory device (e.g., an SD memorycard); to transmit one or more prescriptions to a vestibular stimulationdevice and/or a portable memory device (e.g., an SD memory card); toreceive one or more prescription modifications, updates and/orextensions from a physician control device, a physician support device,a registry and/or a portable memory device (e.g., an SD memory card); totransmit one or more prescription modifications, updates and/orextensions to a vestibular stimulation device and/or a portable memorydevice (e.g., an SD memory card); to receive data associated with thedelivery of one or more thermal waveforms (e.g., idealized thermalwaveforms) from a vestibular stimulation device and/or a portable memorydevice (e.g., an SD memory card); to transmit data associated with thedelivery of one or more thermal waveforms (e.g., idealized thermalwaveforms) to a physician control device, a physician support device, aregistry and/or a portable memory device (e.g., an SD memory card); totransmit patient feedback data to a physician control device, aphysician support device, a registry and/or a portable memory device(e.g., an SD memory card); to receive patient information from avestibular stimulation device and/or a portable memory device (e.g., anSD memory card) and/or to transmit patient information to a physiciancontrol device, a physician support device, a registry and/or a portablememory device (e.g., an SD memory card).

The patient control device may be configured to receive and/or transmitdata over any suitable wired or wireless communications channel,including, but not limited to, a LAN, the Internet, a public telephoneswitching network, Bluetooth, WLAN and the like.

In some embodiments, the patient control device comprises memory, aprocessor and a power supply. As will be appreciated by one of skill inthe art, the processor may be any commercially available or custommicroprocessor. Memory can include, but is not limited to, the followingtypes of devices: cache, ROM, PROM, EPROM, EEPROM, flash memory, SRAMand DRAM. The power supply may be an internal power supply (e.g., one ormore rechargeable batteries that may be recharged without first beingremoved from the physician control device).

The patient control device's memory may comprise any suitable softwareand/or data, including, but not limited to, an operating system,applications, data and input/output (I/O) drivers.

As will be appreciated by one of skill in the art, the patient controldevice may use any suitable operating system, including, but not limitedto, OS/2, AIX, OS/390 or System390 from International Business MachinesCorp. (Armonk, N.Y.), Window CE, Windows NT, Windows95, Windows98,Windows2000, Windows 7 or Windows Vista from Microsoft Corp. (Redmond,Wash.), Mac OS from Apple, Inc. (Cupertino, Calif.), Unix, Linux orAndroid.

As will be appreciated by one of skill in the art, the patient controldevice may comprise any suitable application, including, but not limitedto, one or more programs configured to implement one or more of thevarious features of the present invention. For example, the patientcontrol device may comprise a network module configured to receiveand/or transmit data; a GUI module configured to display informationand/or accept user input; a feedback module configured to receive,transmit, and/or analyze data associated with the delivery of one ormore thermal waveforms, data associated with the fit of one or moreearpieces, patient feedback data and/or patient information; an alertgeneration module configured to generate one or more alert messages; atone generation module configured to produce one or more audible tones;a visual indicator module configured to produce one or more visualindicators and/or a security module configured to prevent unauthorizeduse of the patient control device. In some embodiments, two or more ofthe aforementioned modules are combined to form a single moduleconfigured to carry out the function(s) of each of the individualmodules (e.g., the patient control device may comprise anetwork-feedback module that receives feedback data from a vestibularstimulation device, analyzes the data and transmits the data and theresults of its analysis to a physician control device). In someembodiments, one of the aforementioned modules is split into two or moredistinct modules (e.g., the patient control device may comprise adelivery feedback module that receives data associated with the deliveryof one or more thermal waveforms from a vestibular stimulation deviceand a patient feedback module that receives patient feedback data fromthe a GUI module residing in the patient control device). In someembodiments, one or more of the functions described below with respectto one of the modules described below is performed by one of the othermodules described below (e.g., the network module, rather than thefeedback module may be configured to receive feedback data from avestibular stimulation device, while the feedback module is tasked onlywith analyzing the data).

A. Network Module

In some embodiments, the patient control device comprises a networkmodule configured to receive, retrieve and/or transmit data.

The network module may be configured to receive, retrieve and/ortransmit data from/to any suitable device/module/database, including,but not limited to, other modules residing in the patient controldevice, databases residing in the patient control device, a vestibularstimulation device, a physician control device, a physician supportdevice, a registry, a TED, a sensor and a portable memory device (e.g.,an SD memory card).

The network module may be configured to receive, retrieve and/ortransmit data over any suitable wired or wireless communicationschannel, including, but not limited to, a LAN, the Internet, a publictelephone switching network, Bluetooth, WLAN and the like.

The network module may be configured to receive, retrieve and/ortransmit any suitable data, including, but not limited to, dataassociated with the parameters, indications and/or approvals of one ormore thermal waveforms, one or more prescriptions, controller feedbackdata, data associated with the delivery of one or more thermalwaveforms, data associated with the fit of one or more earpieces,patient feedback data and/or patient information.

In some embodiments, the network module is configured to receive and/orretrieve data associated with the parameters, indications and/orapprovals of one or more thermal waveforms from a waveform databaseresiding in the patient control device, from a vestibular stimulationdevice, from a physician control device, from a physician supportdevice, from a registry and/or from a portable memory device.

In some embodiments, the network module is configured to receive and/orretrieve one or more prescriptions from a prescription database residingin the patient control device, from a vestibular stimulation device,from a physician control device, from a physician support device, from aregistry and/or from a portable memory device.

In some embodiments, the network module is configured to receive and/orretrieve controller feedback data, data associated with the delivery ofone or more thermal waveforms and/or data associated with the fit of oneor more earpieces from a feedback module/database residing in thepatient control device and/or a vestibular stimulation device.

In some embodiments, the network module is configured to receive and/orretrieve patient feedback data and/or patient information from afeedback module/database residing in the patient control device, from aGUI module residing in the patient control device, from a patientinformation database residing in the patient control device, from avestibular stimulation device, from a physician control device, from aphysician support device, from a registry and/or from a portable memorydevice.

In some embodiments, the network module is configured to transmit dataassociated with the parameters, indications and/or approvals of one ormore thermal waveforms to a waveform database residing in the patientcontrol device, to a vestibular stimulation device, to a physiciancontrol device, to a physician support device, to a registry and/or to aportable memory device.

In some embodiments, the network module is configured to transmit one ormore prescriptions to a prescription database residing in the patientcontrol device, to a vestibular stimulation device, to a physiciancontrol device, to a physician support device, to a registry and/or to aportable memory device.

In some embodiments, the network module is configured to transmitcontroller feedback data, data associated with the delivery of one ormore thermal waveforms and/or data associated with the fit of one ormore earpieces to a feedback module/database residing in the patientcontrol device, to a vestibular stimulation device, to a physiciancontrol device, to a physician support device, to a registry and/or to aportable memory device.

In some embodiments, the network module is configured to transmitpatient feedback data and/or patient information to a feedbackmodule/database residing in the patient control device, to a patientinformation database residing in the patient control device, to avestibular stimulation device, to a physician control device, to aphysician support device, to a registry and/or to a portable memorydevice.

In some embodiments, the network module is configured to access adatabase comprising data associated with the parameters, indicationsand/or approvals of one or more thermal waveforms (e.g., idealizedthermal waveforms). For example, the network module maybe configured toaccess a waveform database residing in a vestibular stimulation device,a waveform database residing in the patient control device, a waveformdatabase residing in a physician control device, a waveform databaseresiding in a physician support device, a waveform database residing ina registry and/or a waveform database residing in a portable memorydevice.

In some embodiments, the network module is configured to access adatabase comprising one or more prescriptions. For example, the networkmodule maybe configured to access a prescription database residing in avestibular stimulation device, a prescription database residing in thepatient control device, a prescription database residing in a physiciancontrol device, a prescription database residing in a physician supportdevice, a prescription database residing in a registry and/or aprescription database residing in a portable memory device.

In some embodiments, the network module is configured to access adatabase comprising controller feedback data, data associated with thedelivery of one or more thermal waveforms, data associated with the fitof one or more earpieces, patient feedback data and/or physicianfeedback data. For example, the network module maybe configured toaccess a feedback database residing in a vestibular stimulation device,a feedback database residing in the patient control device, a feedbackdatabase residing in a physician control device, a feedback databaseresiding in a physician support device, a feedback database residing ina registry and/or a feedback database residing in a portable memorydevice.

In some embodiments, the network module is configured to access adatabase comprising patient information. For example, the network modulemaybe configured to access a patient information database residing in avestibular stimulation device, a patient information database residingin the patient control device, a patient information database residingin a physician control device, a patient information database residingin a physician support device, a patient information database residingin a registry and/or a patient information database residing in aportable memory device.

B. Graphical User Interface Module

In some embodiments, the patient control device comprises a GUI moduleconfigured to display information and/or to accept user input. Anysuitable GUI may be used, including, but not limited to, a keyboard, amouse, an LCD display with one or more associated entry keys and aninteractive touch screen. For example, the GUI may comprise a staticpressure touch-sensitive display, a capacitive touch-sensitive display,a resistive touch-sensitive display, an electrostatic capacity proximitysensor, a magnetic proximity sensor and/or an infrared proximity sensor.See, e.g., U.S. Patent Publication Nos. 2011/0271222, 2011/0273575,2011/0275414 and 2011/0275416.

The GUI module may be configured to display any suitable information,including, but not limited to, data associated with the delivery of oneor more thermal waveforms. For example, the GUI module may be configuredto display the current date and/or time (as discussed above with respectto FIG. 10); delivery of one or morethe current temperature(s) of theearpiece(s) associated with the controller; the current temperature(s)of a patient's ear canal(s); the current temperature(s) of a patient'sinner ear(s); the current temperature(s) of the heat sindelivery of oneor morethe current temperature(s) of the earpiece(s) associated with thecontroller; the current temperature(s) of a patient's ear canal(s); thecurrent temperature(s) of a patient's inner ear(s); the currenttemperature(s) of the heat sine controller; one or more targettemperatures (as discussed above with respect to FIG. 11); the amount oftime that has elapsed since the onset of delivery of one or more thermalwaveforms (as discussed above with respect to FIG. 11); the amount oftime remaining in the delivery of one or more thermal waveforms (asdiscussed above with respect to FIG. 11); the amount of time that haselapsed since the onset of a treatment session; the amount of timeremaining in a treatment session; a graphical representation of thethermal waveform being applied (as discussed above with respect to FIG.11); the number of treatment sessions that have been administered for aprescription; the number of treatment sessions remaining in aprescription; the amount of time remaining until a prescription must berenewed/updated; the amount of remaining battery life, an alert message(e.g., a reminder to a patient that he/she is due for a treatmentsession); the target time/temperature parameters of one or moreprescribed thermal waveform(s) (as discussed above with respect to FIG.11); the precise time/temperature parameters of the thermal waveform(s)delivered to a patient; the date/time of delivery of the thermalwaveform(s) delivered to a patient; the temperature(s) of a patient'sear canal(s) at various time points before, during and/or after deliveryof the thermal waveform(s); the temperature(s) of a patient's innerear(s) at various time points before, during and/or after delivery ofthe thermal waveform(s); the fit of the earpiece(s) at various timepoints before, during and/or after delivery of the thermal waveform(s);an estimate of the thermal contact between the earpiece(s) and thepatient's ear canal(s) at various time points before, during and/orafter delivery of the thermal waveform(s); patient-specific timeconstants (e.g., a time constant associated with the transduction ofheat from a patient's ear canal to the inner ear); reaction time (i.e.,how long it took for a patient to react to one or more thermalwaveforms); the effectiveness of one or more thermal waveforms (i.e.,whether and to what extent symptoms were relieved, whether the thermalwaveform(s) enhanced the effectiveness of another agent/therapy, etc.);the stability of a treatment (i.e., how long the effects of thetreatment lasted); the instability of a treatment (i.e., whichsymptom(s) returned and when did it/they return); the presence orabsence of comorbid disorders, injuries and/or diseases; disorder,injury and/or disease modulation(s) and/or modification(s) that occurredas a result of treatment; the cognitive effect(s) of one or more thermalwaveforms; patient compliance (e.g., whether a patient initiateddelivery at the prescribed time, whether a patient completed theprescribed treatment session, whether the earpiece(s) remained properlyfitted in a patient's ear canal(s) for the duration of the treatmentsession, etc.); the mood of a patient at various time points before,during and/or after delivery of one or more thermal waveforms (e.g.,videos/images of a patient that may be used to assess mood); objectivesmeasures of efficacy (e.g., nystamography data, EEG data, MRI data,heart rate data, blood pressure data); subjective measures of efficacy(e.g., a patient-reported pain score); blood chemistry data (e.g., bloodA1c levels, blood glucose levels and blood cortisol levels); salivachemistry data (e.g., saliva cortisol levels); urine chemistry data(e.g., urine cortisol levels)), comments a patient made about his/hertreatment session(s) (e.g., comments made to a physician, submitted inresponse to an automated survey and/or recorded in a treatment diary);the impedance between an earpiece inserted into the ear canal of apatient and an electrode affixed to a second location on/in saidpatient's body (e.g., an electrode placed in or adjacent to thepatient's other ear canal); the rate at which a patient's inner earcools in response to a cooling stimulus (e.g., data from a temperaturesensor, such as thermistor, that monitors how quickly the inner earcools in response to a cooling waveform); the rate at which a patient'sinner ear warms in response to a warming stimulus (e.g., data from atemperature sensor, such as thermistor, that monitors how quickly theinner ear warms in response to a warming waveform) and/or patientcomments regarding the subjective fit of his/her earpiece(s).

The GUI module may be configured to accept any suitable user input,including, but not limited to, patient feedback data and/or patientinformation. For example, the GUI module may be configured to accept apain score and/or patient comments regarding the effectiveness of atreatment session.

In some embodiments, the GUI module is configured to allow a user toinitiate/stop a treatment session (e.g., by pushing/selecting anemergency shutoff button/icon) (as discussed above with respect to FIG.11).

C. Feedback Module

In some embodiments, the patient control device comprises a feedbackmodule configured to receive, transmit and/or analyze data.

The feedback module may be configured to receive and/or transmit datafrom/to any suitable device/module/database, including, but not limitedto, other modules residing in the patient control device, databasesresiding in the patient control device, a vestibular stimulation device,a physician control device, a physician support device, a registry, aTED, a sensor and a portable memory device (e.g., an SD memory card).

The feedback module may be configured to receive and/or transmit dataover any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like.

The feedback module may be configured to receive, transmit and/oranalyze any suitable data, including, but not limited to, controllerfeedback data, data associated with the delivery of one or more thermalwaveforms, data associated with the fit of one or more earpieces,patient feedback data and/or patient information.

In some embodiments, the feedback module is configured to receive and/oranalyze data associated with the delivery of one or more thermalwaveforms and/or data associated with the fit of one or more earpiecesfrom a feedback database residing in the physician control device, fromone or more vestibular stimulation devices. For example, the feedbackmodule may be configured to analyze the accuracy with which one or moreprescribed waveforms was delivered to a patient, the fit of an earpiecebased upon the rate at which the temperature of the earpiece changes inresponse to a cooling/warming waveform, the slew rate associated withone or more TEDs, the impedance between an earpiece positioned in theleft ear canal of a patient and an earpiece positioned in the right earcanal of a patient, the impedance between an earpiece positioned in theear canal of a patient and an electrode affixed to a second locationon/in the patient's body, etc.

In some embodiments, the feedback module is configured to receive and/oranalyze patient feedback data and/or patient information from a GUImodule residing in the patient control device, from a feedback databaseresiding in the patient control device, from a patient informationdatabase residing in the patient, from a vestibular stimulation device,from a physician control device, from a physician support device and/orfrom a portable memory device. For example, the feedback module may beconfigured to analyze the effectiveness of a given thermal waveform orcombination of thermal waveforms (e.g., by analyzing pain scores enteredbefore, during and after a treatment session), the effect(s) of one ormore waveform modifications (e.g., by analyzing whether/how much a givenwaveform modification changed the effectiveness of a thermal waveform intreating a disease/disorder), etc.

In some embodiments, the feedback module is configured to transmit dataassociated with the delivery of one or more thermal waveforms, dataassociated with the fit of one or more earpieces, patient feedback data,physician feedback data, patient information and/or data associated withits analysis to a feedback database residing in the patient controldevice, to a patient information database residing in the patientcontrol device, to a physician control device, to a physician supportdevice, to a registry and/or to a portable memory device (e.g., an SDmemory card).

D. Alert Generation Module

In some embodiments, the patient control device comprises an alertgeneration module configured to generate one or more alert messages.

The alert generation module may be configured to generate any suitablealert message, including, but not limited to, a reminder that a patientis due for a treatment session; a reminder that a patient must enterpatient feedback data (e.g., a pain score) following a treatmentsession; an indication of the number of treatment sessions remaining ina prescription; an error message indicating that a treatment session hasbeen interrupted due to a system error; a reminder that a patient mustcontact his/her physician to update/extend his/her prescription; awarning that the patient control device's internal power supply is lowand a warning that the internal power supply of an associated vestibularstimulation device is low.

In some embodiments, the alert generation module is configured tocommunicate with various devices/modules, including, but not limited to,a vestibular stimulation device, a physician control device, a physiciansupport device, a TED, a sensor, a portable memory device (e.g., an SDmemory card) and other modules of the patient control device. Forexample, the alert generation module may be configured to provideinstructions to the GUI module and/or the tone generation module fordisplaying one or more alert messages and/or for generation an audibletone to alert a user of the presence of the one or more alert messages.The graphical user interface module may be configured to display the oneor more alert messages immediately upon generation or upon interactionwith a user (e.g., an alert notification icon may be generated, with thealert message being displayed only after the user indicates that he/shewishes to view the message).

E. Tone Generation Module

In some embodiments, the patient control device comprises a tonegeneration module configured to produce audible tones. In some suchembodiments, the tone generation module comprises a piezo buzzer.Audible tones may be produced to alert a user to variouscircumstances/events, including, but not limited to, the existence of anunread/unviewed alert message. Audible tones may be generated repeatedlyin response to a single circumstance/event (e.g., an audible tone may begenerated repeatedly until the user views/reads the message) and maybecome progressively louder and/or more frequent with time.

F. Visual Indicator Module

In some embodiments, the patient control device comprises a visualindicator module configured to notify a user of the existence of anunread/unviewed alert message. In some such embodiments, the visualindicator module comprises an LED indicator light. The visual indicatormodule may be activated repeatedly in response to a single alert message(e.g., an LED light may be illuminated repeatedly until the userviews/reads the message) or may remain activated until the userviews/reads the message.

G. Security Module

In some embodiments, the patient control device comprises a securitymodule configured to prevent unauthorized use of the physician controldevice (i.e., to prevent unauthorized persons from using the patientcontrol device, to prevent authorized persons from using the patientcontrol device in an unauthorized manner, etc.).

The security module may be configured to prevent unauthorized use of thepatient control device using any suitable means of security, including,but not limited to, password protection and data encryption. Forexample, the security module may be configured such that a user isrequired to input a designated password prior to entering/viewingpatient feedback data; and/or entering/viewing patient information (asdiscussed above with respect to FIG. 12).

As will be appreciated by one of skill in the art, the patient controldevice may comprise any suitable data, including, but not limited to,static and/or dynamic data used by the operating system, applications,I/O device drivers and other software components, controller feedbackdata, data associated with the parameters, indications and/or approvalsof one or more thermal waveforms (e.g., idealized thermal waveforms),data associated with one or more prescriptions, data associated with thedelivery of one or more thermal waveforms, data associated with the fitof one or more earpieces, patient feedback data and patient information.For example, the patient control device may comprise a waveform databasecomprising data associated with one or more idealized thermal waveforms;a prescription database comprising data associated with one or moreprescriptions; a feedback database comprising controller feedback data,data associated with the delivery of one or more thermal waveforms tothe vestibular system and/or the nervous system of a patient and patientfeedback data and/or a patient history database comprising dataassociated with one or more patients. In some embodiments, two or moreof the aforementioned databases are combined to form a single databasecomprising data from each of the individual databases (e.g., the patientcontrol device may comprise a feedback-history database comprising dataassociated with the delivery of one or more thermal waveforms andpatient information). In some embodiments, one of the aforementioneddatabases is split into two or more distinct databases (e.g., thepatient control device may comprise a delivery feedback databasecomprising data associated with the specific parameters of the thermalwaveform(s) delivered to a patient and a patient feedback databasecomprising patient feedback data). In some embodiments, one or more ofthe data types described below with respect to one of the databasesdescribed below is stored in one of the other databases described below(e.g., the patient information database, rather than the feedbackdatabase, may be configured to receive/store patient feedback data). Insome embodiments, data is transmitted, received and/or stored in acontrolled format (e.g., in a standardized format using forms/programssupplied by a physician support device or a registry). The patientcontrol device may be configured to transmit, receive and store data ina manner that ensures compliance with any and all applicable laws and/orregulations (e.g., the Health Insurance Portability and AccountabilityAct of 1996 (P.L. 104-191; “HIPAA”)).

A. Waveform Database

In some embodiments, the patient control device comprises a waveformdatabase configured to receive, store and/or transmit data associatedwith the parameters, indications and/or approvals of one or more thermalwaveforms (e.g, one or more idealized thermal waveforms). In some suchembodiments, the waveform database is configured such that one or moreof the thermal waveforms stored therein is/are protected (e.g., usersmay be prevented from modifying and/or deleting the idealized thermalwaveform(s) stored in the waveform database).

The waveform database may comprise any suitable type of memoryincluding, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flashmemory, SRAM and DRAM. In some embodiments, the waveform databasecomprises a portable memory device, such as an SD memory card or a USBmemory stick. For example, the waveform database may comprise an SDmemory card interface and one or more prescriptions may be stored on aportable SD memory card.

The waveform database may be configured to receive and/or transmit datafrom/to any suitable device/module/database, including, but not limitedto, modules residing in the patient control device, a vestibularstimulation device, a physician control device, a physician supportdevice, a registry, a TED, a sensor and a portable memory device (e.g.,an SD memory card).

The waveform database may be configured to receive and/or transmit dataover any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like.

B. Prescription Database

In some embodiments, the patient control device comprises a prescriptiondatabase configured to receive, transmit and/or store one or moreprescriptions, wherein each prescription comprising a set ofinstructions for delivering one or more thermal waveforms to thevestibular system and/or the nervous system of a patient.

The prescription database may comprise any suitable type of memoryincluding, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flashmemory, SRAM and DRAM. In some embodiments, the prescription databasecomprises a portable memory device, such as an SD memory card or a USBmemory stick. For example, the prescription database may comprise an SDmemory card interface and one or more prescriptions may be stored on aportable SD memory card.

The prescription database may be configured to receive and/or transmitdata from/to any suitable device/module/database, including, but notlimited to, modules residing in the patient control device, a vestibularstimulation device, a physician control device, a physician supportdevice, a registry, a TED, a sensor and a portable memory device (e.g.,an SD memory card).

The prescription database may be configured to receive and/or transmitdata over any suitable wired or wireless communications channel,including, but not limited to, a LAN, the Internet, a public telephoneswitching network, Bluetooth, WLAN and the like.

C. Feedback Database

In some embodiments, the patient control device comprises a feedbackdatabase configured to receive, transmit and/or store feedback data.

The feedback database may comprise any suitable type of memoryincluding, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flashmemory, SRAM and DRAM. In some embodiments, the feedback databasecomprises a portable memory device, such as an SD memory card or a USBmemory stick. For example, the feedback database may comprise an SDmemory card interface and one or more prescriptions may be stored on aportable SD memory card.

The feedback database may be configured to receive and/or transmitfeedback data from/to any suitable device/module/database, including,but not limited to, modules residing in the patient control device, avestibular stimulation device, a physician control device, a physiciansupport device, a registry, a TED, a sensor and a portable memory device(e.g., an SD memory card).

The feedback database may be configured to receive and/or transmit dataover any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like.

Feedback data may comprise any suitable data, including, but not limitedto, controller feedback data, data associated with the delivery of oneor more thermal waveforms, data associated with the fit of one or moreearpieces, patient feedback data and/or patient information. Forexample, the feedback database may comprise a log file detailing thetarget time/temperature parameters of one or more prescribed thermalwaveform(s); the time/temperature parameters of the thermal waveform(s)delivered to a patient; the date/time of delivery of the thermalwaveform(s) delivered to a patient; the temperature(s) of a patient'sear canal(s) at various time points before, during and/or after deliveryof one or more thermal waveforms; the temperature(s) of a patient'sinner ear(s) at various time points before, during and/or after deliveryof one or more thermal waveforms; the fit of one or more earpieces atvarious time points before, during and/or after delivery of one or morethermal waveforms; an estimate of the thermal contact between one ormore earpieces and a patient's ear canal(s) at various time pointsbefore, during and/or after delivery of one or more thermal waveforms;patient-specific time constants (e.g., a time constant associated withthe transduction of heat from a patient's ear canal to the inner ear); apatient's reaction time (i.e., how long it took for a patient to reactto one or more thermal waveforms); effectiveness of one or more thermalwaveforms (i.e., whether and to what extent symptoms were relieved,whether the thermal waveform(s) enhanced the effectiveness of anotheragent/therapy, etc.); stability of a treatment (i.e., how long theeffects of a treatment lasted); instability of a treatment (i.e., whichsymptom(s) returned and when did it/they return); the presence orabsence of comorbid disorders, injuries and/or diseases; disorder,injury and/or disease modulation(s) and/or modification(s) that occurredas a result of treatment; the cognitive effect(s) of one or more thermalwaveforms; patient compliance (e.g., whether a patient initiateddelivery at the prescribed time, whether a patient completed theprescribed treatment session, whether the earpiece(s) remained properlyfitted in a patient's ear canal(s) for the duration of the treatmentsession, etc.); the mood of a patient at various time points before,during and/or after delivery of one or more thermal waveforms (e.g.,videos/images of a patient that may be used to assess mood); objectivesmeasures of efficacy (e.g., nystamography data, EEG data, MRI data,heart rate data, blood pressure data); subjective measures of efficacy(e.g., a patient-reported pain score); blood chemistry data (e.g., bloodA1c levels, blood glucose levels and blood cortisol levels); salivachemistry data (e.g., saliva cortisol levels); urine chemistry data(e.g., urine cortisol levels)); comments a patient made about his/hertreatment session(s) (e.g., comments made to a physician, submitted inresponse to an automated survey and/or recorded in a treatment diary);the impedance between an earpiece inserted into the ear canal of apatient and an electrode affixed to a second location on/in saidpatient's body (e.g., an electrode placed in or adjacent to thepatient's other ear canal); the rate at which an earpiece is cooled inresponse to a cooling stimulus (e.g., data from a temperature sensor,such as thermistor, that monitors how quickly the earpiece cools inresponse to a cooling waveform); the rate at which an earpiece is warmedin response to a warming stimulus (e.g., data from a temperature sensor,such as a thermistor, that monitors how quickly the earpiece warms inresponse to a warming waveform); the rate at which a patient's ear canaland/or inner ear cooled in response to a cooling stimulus (e.g., datafrom a temperature sensor, such as thermistor, that monitors how quicklythe ear canal and/or the inner ear cools in response to a coolingwaveform); the rate at which a patient's ear canal and/or inner earwarmed in response to a warming stimulus (e.g., data from a temperaturesensor, such as a thermistor, that monitors how quickly the ear canaland/or the inner ear warms in response to a warming waveform) and/orpatient comments regarding the subjective fit of one or more earpieces.

D. Patient History Database

In some embodiments, the patient control device comprises a patienthistory database configured to receive, transmit and/or store patientinformation.

The patient history database may comprise any suitable type of memoryincluding, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flashmemory, SRAM and DRAM. In some embodiments, the patient history databasecomprises a portable memory device, such as an SD memory card or a USBmemory stick. For example, the patient history database may comprise anSD memory card interface and one or more prescriptions may be stored ona portable SD memory card.

The patient history database may be configured to receive and/ortransmit data from/to any suitable device/module/database, including,but not limited to, modules residing in the patient control device, avestibular stimulation device, a physician control device, a physiciansupport device, a registry, a TED, a sensor and a portable memory device(e.g., an SD memory card).

The patient history database may be configured to receive and/ortransmit data over any suitable wired or wireless communicationschannel, including, but not limited to, a LAN, the Internet, a publictelephone switching network, Bluetooth, WLAN and the like.

Patient information may comprise any suitable information that isassociated with a patient, including, but not limited to, the patient'smedical history, the patient's current symptoms (if any), the patient'spresent diagnosis (if any), the patient's current prescriptions (if any)and data associated with the delivery of one or more thermal waveformsto the vestibular system and/or the nervous system of the patient.

As will be appreciated by one of skill in the art, the patient controldevice may comprise any I/O device drivers, including, but not limitedto, software routines accessed through the operating system by theapplications to communicate with devices such as I/O ports, memorycomponents, vestibular stimulation devices, physician control devicesand/or physician support devices.

As will be appreciated by one of skill in the art, the patient controldevice may be configured (e.g., with computer instructions (i.e.,software)) to operate in a plurality of distinct modes. In each mode,the patient control device may be configured to permit access to somefunctionalities/modules and to prevent access to otherfunctionalities/modules. For example, the patient control device may beconfigured to operate in a patient mode, wherein the user is allowed toperform patient-oriented tasks, such as starting/stopping a treatmentsession and/or providing feedback regarding the effectiveness of atreatment session, but is prevented from accessing othermodules/databases/functionalities (e.g., the user may be preventedgenerating, modifying, updating and/or extending prescriptions).Likewise, the patient control device may be configured to operate in anengineer mode, wherein the user is allowed to access all of the patientcontrol device's functionalities/modules. Each mode may be protected viaa unique security measure (e.g., the patient control device may beconfigured such that each mode is protected by a unique password).

As shown in FIGS. 25-27, in some embodiments of the present invention,the patient control device 3 comprises memory 30, a processor 31 and apower supply 32 (e.g., an internal power supply), wherein memory 30 isrepresentative of the overall hierarchy of memory devices containingsoftware and data used to implement the functionality of the patientcontrol device 3 and wherein the processor 31 communicates with thememory 30 via an address/data bus 300. In particular embodiments, memory30 comprises an operating system 30 a, applications 30 b (e.g., anetwork module 3 d configured to receive and/or transmit data, a GUImodule 3 e configured to display information and/or accept user inputand/or a feedback module 3 f configured to receive, transmit, and/oranalyze data associated with the delivery of one or more thermalwaveforms), data 30 c (e.g., a waveform database 3 h comprising dataassociated with the parameters, indications and/or approvals of one ormore thermal waveforms; a prescription database 3 i comprising at leastone prescription comprising a set of instructions for delivering one ormore thermal waveforms to the vestibular system and/or the nervoussystem of a patient; a feedback database 3 j comprising data associatedwith the delivery of one or more thermal waveforms and/or a patienthistory database 3 k comprising patient information) and I/O drivers 30d. In some such embodiments, data 30 c comprises one or more databasesstored on a portable memory device. For example, data 30 c may comprisean SD memory card interface and a portable SD memory card comprising awaveform database 3 h, a prescription database 3 i, a feedback database3 j and/or a patient history database 3 k.

In some embodiments, the network module 3 d is configured to receivedata associated with the parameters, indications and/or approvals of oneor more thermal waveforms from a physician control device, a physiciansupport device, a registry and/or a portable memory device (e.g., an SDmemory card) and to transmit the data to the waveform database 3 h forstorage. In some such embodiments, the data is stored on an SD memorycard inserted into an SD memory card interface.

In some embodiments, the network module 3 d is configured to retrievedata associated with the parameters, indications and/or approvals of oneor more thermal waveforms from the waveform database 3 h, a physiciancontrol device, a physician support device, a registry and/or a portablememory device (e.g., an SD memory card) and to transmit the data to avestibular stimulation device.

In some embodiments, the network module 3 d is configured to receive oneor more prescriptions from a physician control device, a physiciansupport device, a registry and/or a portable memory device (e.g., an SDmemory card) and to transmit the prescription(s) to the prescriptiondatabase 3 i for storage. In some such embodiments, the prescription(s)is/are stored on an SD memory card inserted into an SD memory cardinterface.

In some embodiments, the network module 3 d is configured to retrieveone or more prescriptions from the prescription database 3 i, aphysician control device, a physician support device, a registry and/ora portable memory device (e.g., an SD memory card) and to transmit theprescription(s) to a vestibular stimulation device.

In some embodiments, the network module 3 d is configured to receivecontroller feedback data, data associated with the delivery of one ormore thermal waveforms and/or data associated with the fit of one ormore earpieces from a vestibular stimulation device and/or a portablememory device (e.g., an SD memory card) and to transmit that data to thefeedback database 3 j for storage. In some such embodiments, the data isstored on an SD memory card inserted into an SD memory card interface.

In some embodiments, the network module 3 d is configured to retrievecontroller feedback data, data associated with the delivery of one ormore thermal waveforms and/or data associated with the fit of one ormore earpieces from the feedback database 3 j and to transmit the datato the feedback module 3 f, a physician control device, a physiciansupport device, a registry and/or a portable memory device (e.g., an SDmemory card).

In some embodiments, the network module 3 d is configured to receivepatient feedback data from the GUI module 3 e, a vestibular stimulationdevice and/or a portable memory device (e.g., an SD memory card) and totransmit that data to the feedback database 3 j for storage. In somesuch embodiments, the patient information is stored on an SD memory cardinserted into an SD memory card interface.

In some embodiments, the network module 3 d is configured to retrievepatient feedback data from the feedback database 3 j and to transmit thedata to the feedback module 3 f, a physician control device, a physiciansupport device, a registry and/or a portable memory device (e.g., an SDmemory card).

In some embodiments, the network module 3 d is configured to receivepatient information from the GUI module 3 e, a vestibular stimulationdevice, a physician control device, a physician support device, aregistry and/or a portable memory device (e.g., an SD memory card) andto transmit that data to the patient history database 3 k for storage.In some such embodiments, the patient information is stored on an SDmemory card inserted into an SD memory card interface.

In some embodiments, the network module 3 d is configured to retrievepatient information from the patient history database 3 k and totransmit the patient information to a physician control device, aphysician support device, a registry and/or a portable memory device(e.g., an SD memory card).

Physician Support Device

As noted above, the present invention provides a physician supportdevice for generating and/or modifying the parameters, indicationsand/or approvals of one of more thermal waveforms; for generating,modifying, updating and/or extending one or more prescriptions and/orfor receiving, analyzing and/or transmitting data.

In some embodiments, the physician support device is configured togenerate and/or modify the parameters, indications and/or approvals ofone or more idealized thermal waveforms and to transmit the parameters,indications and/or approvals of the idealized thermal waveform(s) to aphysician control device (e.g., a physician control device of thepresent invention).

In some embodiments, the physician support device comprises, consistsessentially of or consists of a waveform module configured to generateand/or modify the parameters, indications and/or approvals of one ormore idealized thermal waveforms and a network module configured totransmit the parameters, indications and/or approvals of the idealizedthermal waveform(s) to one or more physician control devices.

A physician support device of the present invention may be any suitablecomputing device/system, including, but not limited to, a desktopcomputer, a laptop computer, a handheld computer, a personal digitalassistant (PDA), and a smart phone.

Any conventional security means may be provided to prevent unauthorizedactivation of the physician support device. For example, the physiciansupport device may be password protected.

The physician support device may be configured to receive and/ortransmit and suitable data, including, but not limited to, dataassociated with the parameters, indications and/or approvals of one ormore thermal waveforms, one or more prescriptions, controller feedbackdata, data associated with the delivery of one or more thermalwaveforms, data associated with the fit of one or more earpieces,patient feedback data, physician feedback data and patient information.

The physician support device may be configured to receive and/ortransmit data from/to various devices, including, but not limited to, avestibular stimulation device, a patient control device, a physiciancontrol device, a registry, a TED, a sensor and a portable memory device(e.g., an SD memory card). In some embodiments, the physician supportdevice is configured to receive data associated with the parameters,indications and/or approvals of one or more thermal waveforms (e.g.,idealized thermal waveforms) from a registry and/or a portable memorydevice (e.g., an SD memory card); to transmit data associated with theparameters, indications and/or approvals of one or more thermalwaveforms (e.g., idealized thermal waveforms) to a vestibularstimulation device, a patient control device, a physician controldevice, a registry and/or a portable memory device (e.g., an SD memorycard); to receive one or more prescriptions from a registry and/or aportable memory device (e.g., an SD memory card); to transmit one ormore prescriptions to a vestibular stimulation device, a patient controldevice, a physician control device, a registry and/or a portable memorydevice (e.g., an SD memory card); to transmit one or more prescriptionmodifications, updates and/or extensions to a vestibular stimulationdevice, a patient control device, a physician control device, a registryand/or a portable memory device (e.g., an SD memory card); to receivedata associated with the delivery of one or more thermal waveforms(e.g., idealized thermal waveforms) from a vestibular stimulationdevice, a patient control device, a physician control device and/or aportable memory device (e.g., an SD memory card); to transmit dataassociated with the delivery of one or more thermal waveforms (e.g.,idealized thermal waveforms) to a registry and/or a portable memorydevice (e.g., an SD memory card); to receive patient feedback data froma vestibular stimulation device, a patient control device, a physiciancontrol device and/or a portable memory device (e.g., an SD memorycard); to transmit patient feedback to a registry and/or a portablememory device (e.g., an SD memory card); to receive physician feedbackdata from a physician control device and/or a portable memory device(e.g., an SD memory card); to transmit physician feedback to a registryand/or a portable memory device (e.g., an SD memory card); to receivepatient information from a vestibular stimulation device, a patientcontrol device, a physician control device, a registry and/or a portablememory device (e.g., an SD memory card) and/or to transmit patientinformation to a vestibular stimulation device, a patient controldevice, a physician control device, a registry and/or a portable memorydevice (e.g., an SD memory card).

The physician support device may be configured to receive and/ortransmit data over any suitable wired or wireless communicationschannel, including, but not limited to, a LAN, the Internet, a publictelephone switching network, Bluetooth, WLAN and the like.

In some embodiments, the physician support device comprises memory, aprocessor and a power supply. As will be appreciated by one of skill inthe art, the processor may be any commercially available or custommicroprocessor. Memory can include, but is not limited to, the followingtypes of devices: cache, ROM, PROM, EPROM, EEPROM, flash memory, SRAMand DRAM. The power supply may be an internal power supply (e.g., one ormore rechargeable batteries that may be recharged without first beingremoved from the physician control device).

The physician support device's memory may comprise any suitable softwareand/or data, including, but not limited to, an operating system,applications, data and input/output (I/O) drivers.

As will be appreciated by one of skill in the art, the physician supportdevice may use any suitable operating system, including, but not limitedto, OS/2, AIX, OS/390 or System390 from International Business MachinesCorp. (Armonk, N.Y.), Window CE, Windows NT, Windows95, Windows98,Windows2000, Windows 7 or Windows Vista from Microsoft Corp. (Redmond,Wash.), Mac OS from Apple, Inc. (Cupertino, Calif.), Unix, Linux orAndroid.

As will be appreciated by one of skill in the art, the physician supportdevice may comprise any suitable application, including, but not limitedto, one or more programs configured to implement one or more of thevarious features of the present invention. For example, the physiciancontrol device may comprise a waveform module that enables a user togenerate and/or modify the parameters, indications and/or approvals ofone or more thermal waveforms; a treatment module that enables a user togenerate, modify, update and/or extend a prescription comprising a setof instructions for delivering one or more thermal waveforms to thevestibular system and/or the nervous system of a patient; a networkmodule configured to receive and/or transmit data; a GUI moduleconfigured to display information and/or accept user input; a feedbackmodule configured to receive, transmit, and/or analyze data associatedwith the delivery of one or more thermal waveforms, data associated withthe fit of one or more earpieces, patient feedback data, physicianfeedback data and/or patient information; an alert generation moduleconfigured to generate one or more alert messages; a tone generationmodule configured to produce one or more audible tones; a visualindicator module configured to produce one or more visual indicatorsand/or a security module configured to prevent unauthorized use of thephysician support device. In some embodiments, two or more of theaforementioned modules are combined to form a single module configuredto carry out the function(s) of each of the individual modules (e.g.,the physician support device may comprise a waveform-treatment modulethat enables a user to generate and/or modify one or more thermalwaveforms and to generate, modify, update and/or extend a prescription).In some embodiments, one of the aforementioned modules is split into twoor more distinct modules (e.g., the physician support device maycomprise a waveform generation module that enables a user to generatethe parameters, indications and/or approvals of one or more thermalwaveforms and a waveform update module that enables a user to modify theparameters, indications and/or approvals of one or more thermalwaveforms). In some embodiments, one or more of the functions describedbelow with respect to one of the modules described below is performed byone of the other modules described below (e.g., the treatment module,rather than the waveform module, may be configured to modify theparameters, indications and/or approvals of one or more thermalwaveforms).

A. Waveform Module

In some embodiments, the physician support device comprises a waveformmodule whereby a user may generate and/or modify the parameters,indications and/or approvals of one or more thermal waveforms.

In some embodiments, the waveform module comprises software that enablesa user to generate and/or modify the parameters of one or more thermalwaveforms by point-to-point design and/or by utilizing mathematicalfunctions. For example, the waveform module may comprise software thatenables a user to generate and/or modify the parameters of a thermalwaveform by selecting/altering one or more parameters, including, butnot limited to, shape, frequency, amplitude and duration. In someembodiments, the waveform module enables a user to retrieve/select athermal waveform from a database and then modify the parameters of thatthermal waveform to generate a new thermal waveform.

In some embodiments, the waveform module comprises software that enablesa user to generate and/or modify the parameters, indications and/orapprovals of one or more thermal waveforms using an interactive touchscreen. For example, the waveform module may comprise software thatenables a user to generate the parameters of a thermal waveform bydrawing the desired waveform on an interactive touch screen (asdiscussed above with respect to FIG. 3). Similarly, the waveform modulemay enable a user to modify the parameters of a thermal waveform byhighlighting one or more points on the waveform and moving the point(s)to a new location (e.g., a higher/lower temperature) (as discussed abovewith respect to FIG. 4).

In some embodiments, the waveform module comprises software thatautomatically adjusts the parameters of the thermal waveform(s) createdby a user to account for system limitations. For example, the waveformmodule may comprise software that automatically adjusts the slope of athermal waveform in accordance with the minimum/maximum temperatureand/or the rate of temperature change that is achievable using aparticular combination of earpiece(s), TED(s), etc. That is, thewaveform module may comprise software that prevents a user fromgenerating parameters for a thermal waveform that cannot be deliveredbecause of system limitations.

In some embodiments, the waveform module comprises software that enablesa user to protect one or more thermal waveforms (i.e., to prevent one ormore users from modifying the parameters, indications and/or approvalsof the thermal waveform(s) and/or from deleting the thermal waveform(s)from a waveform database). For example, the waveform module may comprisesoftware that enables a user to protect one or more idealized thermalwaveforms (e.g., by requiring users to enter a specified password priorto modifying and/or deleting the idealized thermal waveform(s)).

In some embodiments, the waveform module comprises software that enablesa user to remove the protected status from one or more thermalwaveforms. For example, the waveform module may comprise software thatenables a user to remove the protected status from one or more idealizedthermal waveforms (e.g., by entering the appropriate password).

In some embodiments, the waveform module is configured to automaticallygenerate and/or modify the parameters, indications and/or approvals ofone or more thermal waveforms (e.g., idealized thermal waveforms) inresponse to data received from one or more devices/modules. For example,the waveform module may be configured to automatically update one ormore thermal waveforms responsive to data received from one or more TEDsand/or one or more sensors.

The waveform module may be configured to retrieve the parameters,indications and/or approvals of one or more thermal waveforms from anysuitable database, including, but not limited to, a waveform databaseresiding in a vestibular stimulation device, a waveform databaseresiding in a patient control device, a waveform database residing in aphysician control device, a waveform database residing in the physiciansupport device, a waveform database residing in a registry and/or awaveform database residing in a portable memory device (e.g., an SDmemory card).

Waveform parameters, indications and/or approvals generated and/ormodified by the waveform module may be stored in a database. In someembodiments, the generated/modified parameters, indications and/orapprovals are stored in a waveform database comprising data associatedwith the parameters, indications and/or approvals of one or more thermalwaveforms (e.g., idealized thermal waveforms). For example, thegenerated/modified waveform parameters, indications and/or approvals maybe stored in a waveform database residing in a vestibular stimulationdevice, a waveform database residing in a patient control device, awaveform database residing in a physician control device, a waveformdatabase residing in the physician support device, a waveform databaseresiding in a registry and/or a waveform database residing in a portablememory device (e.g., an SD memory card).

B. Treatment Module

In some embodiments, the physician support device comprises a treatmentmodule whereby a user (e.g., a physician) may generate, modify, updateand/or extend a prescription. For example, the treatment module mayenable a user to generate, modify, update and/or extend a prescriptioncomprising a set of instructions for delivering one or more thermalwaveforms to the vestibular system and/or the nervous system of apatient.

In some embodiments, the treatment module comprises software thatenables a user to select one or more thermal waveforms from a database(e.g., an idealized thermal waveform from an idealized waveformdatabase) and to provide instructions as to when/how each of thosewaveforms should be administered. For example, a treatment module maycomprise software that enables a user to provide instructions as to howlong a treatment schedule is to last (as discussed above with respect toFIG. 5), to provide instructions as to how many treatments may beadministered each day (as discussed above with respect to FIG. 5), toprovide instructions as to how often each thermal waveform is to beadministered (as discussed above with respect to FIG. 6), to provideinstructions as to what time(s) of day each thermal waveform is to beadministered (as discussed above with respect to FIGS. 6 and 9), toselect one or more idealized thermal waveforms from a database (asdiscussed above with respect to FIG. 7), to provide instructionsregarding whether each of the selected thermal waveforms is to bedelivered to the right and/or left ear canal of a patient (as discussedabove with respect to FIG. 8), etc.

In some embodiments, the treatment module comprises software thatenables a user to modify, update and/or extend a prescription bychanging one or more parameters of the prescription (as discussed abovewith respect to FIG. 10), including, but not limited to, which thermalwaveform(s) are delivered, frequency with which the thermal waveform(s)is/are delivered, and the expiration date of the prescription. Anysuitable prescription may be modified, updated and/or extended,including, but not limited to, prescriptions stored in a prescriptiondatabase (e.g., a prescription database residing in a vestibularstimulation device, in a patient control device, in a physician controldevice, in the physician support device or in a portable memory device,such as a portable SD memory card).

The treatment module may be configured to retrieve/select thermalwaveforms from any suitable database, including, but not limited to, awaveform database residing in a vestibular stimulation device, awaveform database residing in a patient control device, a waveformdatabase residing in a physician control device, a waveform databaseresiding in the physician support device, a waveform database residingin a registry and/or a waveform database residing in a portable memorydevice (e.g., an SD memory card).

The treatment module may be configured to retrieve prescriptions fromany suitable database, including, but not limited to, a prescriptiondatabase residing in a vestibular stimulation device, a prescriptiondatabase residing in a patient control device, a prescription databaseresiding in a physician control device, a prescription database residingin the physician support device, a prescription database residing in aregistry and/or a prescription database residing in a portable memorydevice (e.g., an SD memory card).

Prescriptions generated, modified, updated and/or extended by thetreatment module may be added to a database comprising one or moreprescriptions. For example, the prescriptions may be stored in aprescription database residing in a vestibular stimulation device, aprescription database residing in a patient control device, aprescription database residing in a physician control device, aprescription database residing in the physician support device, aprescription database residing in a registry and/or a prescriptiondatabase residing in a portable memory device.

C. Network Module

In some embodiments, the physician support device comprises a networkmodule configured to receive, retrieve and/or transmit data.

The network module may be configured to receive, retrieve and/ortransmit data from/to any suitable device/module/database, including,but not limited to, other modules residing in the physician supportdevice, databases residing in the physician support device, a vestibularstimulation device, a patient control device, a physician controldevice, a registry, a TED, a sensor and a portable memory device (e.g.,an SD memory card).

The network module may be configured to receive, retrieve and/ortransmit data over any suitable wired or wireless communicationschannel, including, but not limited to, a LAN, the Internet, a publictelephone switching network, Bluetooth, WLAN and the like.

The network module may be configured to receive, retrieve and/ortransmit any suitable data, including, but not limited to, dataassociated with the parameters, indications and/or approvals of one ormore thermal waveforms, one or more prescriptions, controller feedbackdata, data associated with the delivery of one or more thermalwaveforms, data associated with the fit of one or more earpieces,patient feedback data, physician feedback data and/or patientinformation.

In some embodiments, the network module is configured to receive and/orretrieve data associated with the parameters, indications and/orapprovals of one or more thermal waveforms from a waveformmodule/database residing in the physician support device, from avestibular stimulation device, from a patient control device, from aphysician control device, from a registry and/or from a portable memorydevice.

In some embodiments, the network module is configured to receive and/orretrieve one or more prescriptions from a treatment module residing inthe physician support device, from a prescription database residing inthe physician support device, from a vestibular stimulation device, froma patient control device, from a physician control device, from aregistry and/or from a portable memory device.

In some embodiments, the network module is configured to receive and/orretrieve controller feedback data, data associated with the delivery ofone or more thermal waveforms and/or data associated with the fit of oneor more earpieces from a feedback module/database residing in thephysician support device, from a vestibular stimulation device and/orfrom a patient control device.

In some embodiments, the network module is configured to receive and/orretrieve patient feedback data, physician feedback data and/or patientinformation from a feedback module/database residing in the physiciansupport device, from a GUI module residing in the physician supportdevice, from a patient information database residing in the physiciansupport device, from a vestibular stimulation device, from a patientcontrol device, from a physician control device, from a registry and/orfrom a portable memory device.

In some embodiments, the network module is configured to transmit dataassociated with the parameters, indications and/or approvals of one ormore thermal waveforms to a waveform module/database residing in thephysician support device, to a treatment module residing in thephysician support device, to a vestibular stimulation device, to apatient control device, to a physician control device, to a registryand/or to a portable memory device.

In some embodiments, the network module is configured to transmit one ormore prescriptions to a treatment module residing in the physiciansupport device, to a prescription database residing in the physiciansupport device, to a vestibular stimulation device, to a patient controldevice, to a physician control device, to a registry and/or to aportable memory device.

In some embodiments, the network module is configured to transmitcontroller feedback data, data associated with the delivery of one ormore thermal waveforms and/or data associated with the fit of one ormore earpieces to a feedback module/database residing in the physiciansupport device, to a vestibular stimulation device, to a patient controldevice, to a physician control device, to a registry and/or to aportable memory device.

In some embodiments, the network module is configured to transmitpatient feedback data, physician feedback data and/or patientinformation to a feedback module/database residing in the physiciansupport device, to a patient information database residing in thephysician support device, to a vestibular stimulation device, to apatient control device, to a physician control device, to a registryand/or to a portable memory device.

In some embodiments, the network module is configured to access adatabase comprising data associated with the parameters, indicationsand/or approvals of one or more thermal waveforms (e.g., idealizedthermal waveforms). For example, the network module maybe configured toaccess a waveform database residing in a vestibular stimulation device,a waveform database residing in a patient control device, a waveformdatabase residing in a physician control device, a waveform databaseresiding in the physician support device, a waveform database residingin a registry and/or a waveform database residing in a portable memorydevice.

In some embodiments, the network module is configured to access adatabase comprising one or more prescriptions. For example, the networkmodule maybe configured to access a prescription database residing in avestibular stimulation device, a prescription database residing in apatient control device, a prescription database residing in a physiciancontrol device, a prescription database residing in the physiciansupport device, a prescription database residing in a registry and/or aprescription database residing in a portable memory device.

In some embodiments, the network module is configured to access adatabase comprising controller feedback data, data associated with thedelivery of one or more thermal waveforms, data associated with the fitof one or more earpieces, patient feedback data and/or physicianfeedback data. For example, the network module maybe configured toaccess a feedback database residing in a vestibular stimulation device,a feedback database residing in a patient control device, a feedbackdatabase residing in a physician control device, a feedback databaseresiding in the physician support device, a feedback database residingin a registry and/or a feedback database residing in a portable memorydevice.

In some embodiments, the network module is configured to access adatabase comprising patient information. For example, the network modulemaybe configured to access a patient information database residing in avestibular stimulation device, a patient information database residingin a patient control device, a patient information database residing ina physician control device, a patient information database residing inthe physician support device, a patient information database residing ina registry and/or a patient information database residing in a portablememory device.

D. Graphical User Interface Module

In some embodiments, the physician support device comprises a GUI moduleconfigured to display information and/or to accept user input. Anysuitable GUI may be used, including, but not limited to, a keyboard, amouse, an LCD display with one or more associated entry keys and aninteractive touch screen. For example, the GUI may comprise a staticpressure touch-sensitive display, a capacitive touch-sensitive display,a resistive touch-sensitive display, an electrostatic capacity proximitysensor, a magnetic proximity sensor and/or an infrared proximity sensor.See, e.g., U.S. Patent Publication Nos. 2011/0271222, 2011/0273575,2011/0275414 and 2011/0275416.

The GUI module may be configured to display any suitable information,including, but not limited to, data associated with the delivery of oneor more thermal waveforms. For example, the GUI module may be configuredto display the current date and/or time (as discussed above with respectto FIG. 10); one or more target temperatures (as discussed above withrespect to FIG. 11); the number of treatment sessions that have beenadministered for a prescription; the number of treatment sessionsremaining in a prescription; the amount of time remaining until aprescription must be renewed/updated; the amount of remaining batterylife, an alert message (e.g., a reminder to a physician that he/sheneeds to modify, update and/or extend a prescription); the targettime/temperature parameters of one or more prescribed thermalwaveform(s) (as discussed above with respect to FIG. 11); the precisetime/temperature parameters of the thermal waveform(s) delivered to apatient; the date/time of delivery of the thermal waveform(s) deliveredto a patient; the temperature(s) of a patient's ear canal(s) at varioustime points before, during and/or after delivery of the thermalwaveform(s); the temperature(s) of a patient's inner ear(s) at varioustime points before, during and/or after delivery of the thermalwaveform(s); the fit of the earpiece(s) at various time points before,during and/or after delivery of the thermal waveform(s); an estimate ofthe thermal contact between the earpiece(s) and the patient's earcanal(s) at various time points before, during and/or after delivery ofthe thermal waveform(s); patient-specific time constants (e.g., a timeconstant associated with the transduction of heat from a patient's earcanal to the inner ear); reaction time (i.e., how long it took for apatient to react to one or more thermal waveforms); the effectiveness ofone or more thermal waveforms (i.e., whether and to what extent symptomswere relieved, whether the thermal waveform(s) enhanced theeffectiveness of another agent/therapy, etc.); the stability of atreatment (i.e., how long the effects of the treatment lasted); theinstability of a treatment (i.e., which symptom(s) returned and when didit/they return); the presence or absence of comorbid disorders, injuriesand/or diseases; disorder, injury and/or disease modulation(s) and/ormodification(s) that occurred as a result of treatment; the cognitiveeffect(s) of one or more thermal waveforms; patient compliance (e.g.,whether a patient initiated delivery at the prescribed time, whether apatient completed the prescribed treatment session, whether theearpiece(s) remained properly fitted in a patient's ear canal(s) for theduration of the treatment session, etc.); the mood of a patient atvarious time points before, during and/or after delivery of one or morethermal waveforms (e.g., videos/images of a patient that may be used toassess mood); objectives measures of efficacy (e.g., nystamography data,EEG data, MRI data, heart rate data, blood pressure data); subjectivemeasures of efficacy (e.g., a patient-reported pain score); bloodchemistry data (e.g., blood A1c levels, blood glucose levels and bloodcortisol levels); saliva chemistry data (e.g., saliva cortisol levels);urine chemistry data (e.g., urine cortisol levels)), comments a patientmade about his/her treatment session(s) (e.g., comments made to aphysician, submitted in response to an automated survey and/or recordedin a treatment diary); the impedance between an earpiece inserted intothe ear canal of a patient and an electrode affixed to a second locationon/in said patient's body (e.g., an electrode placed in or adjacent tothe patient's other ear canal); the rate at which a patient's inner earcools in response to a cooling stimulus (e.g., data from a temperaturesensor, such as thermistor, that monitors how quickly the inner earcools in response to a cooling waveform); the rate at which a patient'sinner ear warms in response to a warming stimulus (e.g., data from atemperature sensor, such as thermistor, that monitors how quickly theinner ear warms in response to a warming waveform); patient commentsregarding the subjective fit of his/her earpiece(s); physician commentsregarding the effectiveness of one or more thermal waveforms and/orphysician comments regarding the effect(s) of one or more waveformmodifications.

The GUI module may be configured to accept any suitable user input,including, but not limited to, instructions for generating and/ormodifying the parameters, indications and/or approvals of a thermalwaveforms and/or instructions for generating, modifying, updating and/orextending a prescription.

E. Feedback Module

In some embodiments, the physician support device comprises a feedbackmodule configured to receive, transmit and/or analyze data.

The feedback module may be configured to receive and/or transmit datafrom/to any suitable device/module/database, including, but not limitedto, other modules residing in the physician support device, databasesresiding in the physician support device, a vestibular stimulationdevice, a patient control device, a physician control device, aregistry, a TED, a sensor and a portable memory device (e.g., an SDmemory card).

The feedback module may be configured to receive and/or transmit dataover any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like.

The feedback module may be configured to receive, transmit and/oranalyze any suitable data, including, but not limited to, controllerfeedback data, data associated with the delivery of one or more thermalwaveforms, data associated with the fit of one or more earpieces,patient feedback data, physician feedback data and/or patientinformation.

In some embodiments, the feedback module is configured to receive and/oranalyze controller feedback data, data associated with the delivery ofone or more thermal waveforms, data associated with the fit of one ormore earpieces, patient feedback data, physician feedback data and/orpatient information from a GUI module residing in the physician supportdevice, from a feedback database residing in the physician supportdevice, from a patient information database residing in the physiciansupport device, from a vestibular stimulation device, from a patientcontrol device, from a physician control device and/or from a portablememory device (e.g., an SD memory card). For example, the feedbackmodule may be configured to analyze the accuracy with which one or moreprescribed waveforms was delivered to a patient, the fit of an earpiecebased upon the rate at which the temperature of the earpiece changes inresponse to a cooling/warming waveform, the slew rate associated withone or more TEDs, the impedance between an earpiece positioned in theleft ear canal of a patient and an earpiece positioned in the right earcanal of a patient, the impedance between an earpiece positioned in theear canal of a patient and an electrode affixed to a second locationon/in the patient's body; the effectiveness of a given thermal waveformor combination of thermal waveforms (e.g., by analyzing pain scoresentered before, during and after a treatment session); the effect(s) ofone or more waveform modifications (e.g., by analyzing whether/how mucha given waveform modification changed the effectiveness of a thermalwaveform in treating a disease/disorder), etc.

In some embodiments, the feedback module is configured to analyze data(e.g., patient feedback data, physician feedback data and/or patientinformation) to identify modifications that are likely to increase theeffectiveness of a given thermal waveform, class of thermal waveforms orcombination of thermal waveforms; to identify newdiseases/disorders/injuries for which a given thermal waveform, class ofthermal waveforms, combination of thermal waveforms and/or treatmentregimen may provide an effective treatment; to predict which thermalwaveform(s) or combination(s) of thermal waveforms may be most effectivein treating a given disease/disorder/injury; to identify thermalwaveforms, classes of thermal waveforms and/or combinations of thermalwaveforms that are not likely to be effective in the treatment of agiven disease/disorder/injury and/or to identify waveformcharacteristics that may be linked to increased/decreased efficacy withregard to the treatment of a given disease/disorder/injury. For example,the feedback module may be configured to identify new idealized thermalwaveforms by identifying one or more diseases/disorders/injuries forwhich a thermal waveform or class of waveforms is likely to be aneffective treatment (e.g., by identifying a new thermal waveform thatbelongs to a class of waveforms known to be effective in treating one ormore diseases/disorders/injuries). Likewise, the feedback module may beconfigured to identify one or more additionaldiseases/disorders/injuries for which a previously identified idealizedthermal waveform is likely to be an effective treatment (e.g., byidentifying, in a population of patients receiving treatment with anidealized thermal waveform for treatment of a firstdisease/disorder/injury, one or more co-morbiddiseases/disorders/injuries that also appear to be effectively treatedby the idealized thermal waveform). Conversely, the feedback module maybe configured to identify one or more diseases/disorders/injuries forwhich a previously identified idealized thermal waveform is not likelyto be an effective treatment (e.g., one or more of thediseases/disorders/injuries for which an idealized thermal waveform hadpreviously been indicated and/or approved may be removed from the listof indications for that thermal waveform or for the class of thermalwaveforms to which it belongs).

In some embodiments, the feedback module is configured to transmit dataassociated with its analysis to a feedback database residing in thephysician support device, to a patient information database residing inthe physician support device, to a vestibular stimulation device, to apatient control device, to a physician control device and/or to aportable memory device (e.g., an SD memory card).

F. Alert Generation Module

In some embodiments, the physician support device comprises an alertgeneration module configured to generate one or more alert messages.

The alert generation module may be configured to generate any suitablealert message, including, but not limited to, an alert indicating thatphysician feedback data has been received from a physician controldevice; a reminder to analyze previously received physician feedbackdata; an alert indicating that one or more idealized thermal waveformshas been modified and an alert indicating that a given modification islikely to increase/decrease the effectiveness of a given thermalwaveform and/or an alert indicating that a given thermal waveform, classof thermal waveforms or combination of thermal waveforms has beenidentified as being indicated and/or approved for use in the treatmentof a disease/disorder.

In some embodiments, the alert generation module is configured tocommunicate with various devices/modules, including, but not limited to,a vestibular stimulation device, a patient control device, a physiciancontrol device, a registry, a portable memory device (e.g., an SD memorycard) and other modules of the physician support device. For example,the alert generation module may be configured to provide instructions tothe GUI module and/or the tone generation module for displaying one ormore alert messages and/or for generation an audible tone to alert auser of the presence of the one or more alert messages. The graphicaluser interface module may be configured to display the one or more alertmessages immediately upon generation or upon interaction with a user(e.g., an alert notification icon may be generated, with the alertmessage being displayed only after the user indicates that he/she wishesto view the message).

G. Tone Generation Module

In some embodiments, the physician support device comprises a tonegeneration module configured to produce audible tones. In some suchembodiments, the tone generation module comprises a piezo buzzer.Audible tones may be produced to alert a user to variouscircumstances/events, including, but not limited to, the existence of anunread/unviewed alert message. Audible tones may be generated repeatedlyin response to a single circumstance/event (e.g., an audible tone may begenerated repeatedly until the user views/reads the message) and maybecome progressively louder and/or more frequent with time.

H. Visual Indicator Module

In some embodiments, the physician support device comprises a visualindicator module configured to notify a user of the existence of anunread/unviewed alert message. In some such embodiments, the visualindicator module comprises an LED indicator light. The visual indicatormodule may be activated repeatedly in response to a single alert message(e.g., an LED light may be illuminated repeatedly until the userviews/reads the message) or may remain activated until the userviews/reads the message.

I. Security Module

In some embodiments, the physician support device comprises a securitymodule configured to prevent unauthorized use of the physician supportdevice (i.e., to prevent unauthorized persons from using the physiciansupport device, to prevent authorized persons from using the physiciansupport device in an unauthorized manner, etc.).

The security module may be configured to prevent unauthorized use of thephysician support device using any suitable means of security,including, but not limited to, password protection and data encryption.For example, the security module may be configured such that a user isrequired to input a designated password prior to generating and/ormodifying a thermal waveform; generating, modifying, updating and/orextending a prescription; entering/viewing patient feedback data;viewing/analyzing physician feedback data and/or entering/viewingpatient information (as discussed above with respect to FIG. 12).

As will be appreciated by one of skill in the art, the physician supportdevice may comprise any suitable data, including, but not limited to,static and/or dynamic data used by the operating system, applications,I/O device drivers and other software components, controller feedbackdata, data associated with the parameters, indications and/or approvalsof one or more thermal waveforms (e.g., idealized thermal waveforms),data associated with one or more prescriptions, data associated with thedelivery of one or more thermal waveforms, data associated with the fitof one or more earpieces, patient feedback data, physician feedback dataand patient information. For example, the physician support device maycomprise a waveform database comprising data associated with one or moreidealized thermal waveforms; a prescription database comprising dataassociated with one or more prescriptions; a feedback databasecomprising controller feedback data, data associated with the deliveryof one or more thermal waveforms to the vestibular system and/or thenervous system of a patient, patient feedback data and physicianfeedback data and/or a patient history database comprising dataassociated with one or more patients. In some embodiments, two or moreof the aforementioned databases are combined to form a single databasecomprising data from each of the individual databases (e.g., thephysician support device may comprise a feedback-history databasecomprising data associated with the delivery of one or more thermalwaveforms and patient information). In some embodiments, one of theaforementioned databases is split into two or more distinct databases(e.g., the physician support device may comprise a delivery feedbackdatabase comprising data associated with the specific parameters of thethermal waveform(s) delivered to a patient, a patient feedback databasecomprising patient feedback data and a physician feedback databasecomprising physician feedback data). In some embodiments, one or more ofthe data types described below with respect to one of the databasesdescribed below is stored in one of the other databases described below(e.g., the patient information database, rather than the feedbackdatabase, may be configured to receive/store patient feedback data). Insome embodiments, data is transmitted, received and/or stored in acontrolled format (e.g., in a standardized format using forms/programssupplied by the physician support device or a registry). The physiciansupport device may be configured to transmit, receive and store data ina manner that ensures compliance with any and all applicable laws and/orregulations (e.g., the Health Insurance Portability and AccountabilityAct of 1996 (P.L. 104-191; “HLPAA”)).

A. Waveform Database

In some embodiments, the physician support device comprises a waveformdatabase configured to receive, store and/or transmit data associatedwith the parameters, indications and/or approvals of one or more thermalwaveforms (e.g, one or more idealized thermal waveforms). In some suchembodiments, the waveform database is configured such that one or moreof the thermal waveforms stored therein is/are protected (e.g., usersmay be prevented from modifying and/or deleting the idealized thermalwaveform(s) stored in the waveform database).

The waveform database may comprise any suitable type of memoryincluding, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flashmemory, SRAM and DRAM. In some embodiments, the waveform databasecomprises a portable memory device, such as an SD memory card or a USBmemory stick. For example, the waveform database may comprise an SDmemory card interface and one or more prescriptions may be stored on aportable SD memory card.

The waveform database may be configured to receive and/or transmit datafrom/to any suitable device/module/database, including, but not limitedto, modules residing in the physician support device, a vestibularstimulation device, a patient control device, a physician controldevice, a registry, a TED, a sensor and a portable memory device (e.g.,an SD memory card).

The waveform database may be configured to receive and/or transmit dataover any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like.

B. Prescription Database

In some embodiments, the physician support device comprises aprescription database configured to receive, transmit and/or store oneor more prescriptions, wherein each prescription comprising a set ofinstructions for delivering one or more thermal waveforms to thevestibular system and/or the nervous system of a patient.

The prescription database may comprise any suitable type of memoryincluding, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flashmemory, SRAM and DRAM. In some embodiments, the prescription databasecomprises a portable memory device, such as an SD memory card or a USBmemory stick. For example, the prescription database may comprise an SDmemory card interface and one or more prescriptions may be stored on aportable SD memory card.

The prescription database may be configured to receive and/or transmitdata from/to any suitable device/module/database, including, but notlimited to, modules residing in the physician support device, avestibular stimulation device, a patient control device, a physiciancontrol device, a registry, a TED, a sensor and a portable memory device(e.g., an SD memory card).

The prescription database may be configured to receive and/or transmitdata over any suitable wired or wireless communications channel,including, but not limited to, a LAN, the Internet, a public telephoneswitching network, Bluetooth, WLAN and the like.

C. Feedback Database

In some embodiments, the physician support device comprises a feedbackdatabase configured to receive, transmit and/or store feedback data.

The feedback database may comprise any suitable type of memoryincluding, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flashmemory, SRAM and DRAM. In some embodiments, the feedback databasecomprises a portable memory device, such as an SD memory card or a USBmemory stick. For example, the feedback database may comprise an SDmemory card interface and one or more prescriptions may be stored on aportable SD memory card.

The feedback database may be configured to receive and/or transmitfeedback data from/to any suitable device/module/database, including,but not limited to, modules residing in the physician support device, avestibular stimulation device, a patient control device, a physiciancontrol device, a registry, a TED, a sensor and a portable memory device(e.g., an SD memory card).

The feedback database may be configured to receive and/or transmit dataover any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like.

Feedback data may comprise any suitable data, including, but not limitedto, controller feedback data, data associated with the delivery of oneor more thermal waveforms, data associated with the fit of one or moreearpieces, patient feedback data, physician feedback data and/or patientinformation. For example, the feedback database may comprise a log filedetailing the target time/temperature parameters of one or moreprescribed thermal waveform(s); the time/temperature parameters of thethermal waveform(s) delivered to a patient; the date/time of delivery ofthe thermal waveform(s) delivered to a patient; the temperature(s) of apatient's ear canal(s) at various time points before, during and/orafter delivery of one or more thermal waveforms; the temperature(s) of apatient's inner ear(s) at various time points before, during and/orafter delivery of one or more thermal waveforms; the fit of one or moreearpieces at various time points before, during and/or after delivery ofone or more thermal waveforms; an estimate of the thermal contactbetween one or more earpieces and a patient's ear canal(s) at varioustime points before, during and/or after delivery of one or more thermalwaveforms; patient-specific time constants (e.g., a time constantassociated with the transduction of heat from a patient's ear canal tothe inner ear); a patient's reaction time (i.e., how long it took for apatient to react to one or more thermal waveforms); effectiveness of oneor more thermal waveforms (i.e., whether and to what extent symptomswere relieved, whether the thermal waveform(s) enhanced theeffectiveness of another agent/therapy, etc.); stability of a treatment(i.e., how long the effects of a treatment lasted); instability of atreatment (i.e., which symptom(s) returned and when did it/they return);the presence or absence of comorbid disorders, injuries and/or diseases;disorder, injury and/or disease modulation(s) and/or modification(s)that occurred as a result of treatment; the cognitive effect(s) of oneor more thermal waveforms; patient compliance (e.g., whether a patientinitiated delivery at the prescribed time, whether a patient completedthe prescribed treatment session, whether the earpiece(s) remainedproperly fitted in a patient's ear canal(s) for the duration of thetreatment session, etc.); the mood of a patient at various time pointsbefore, during and/or after delivery of one or more thermal waveforms(e.g., videos/images of a patient that may be used to assess mood);objectives measures of efficacy (e.g., nystamography data, EEG data, MRIdata, heart rate data, blood pressure data); subjective measures ofefficacy (e.g., a patient-reported pain score); blood chemistry data(e.g., blood Ale levels, blood glucose levels and blood cortisollevels); saliva chemistry data (e.g., saliva cortisol levels); urinechemistry data (e.g., urine cortisol levels)); comments a patient madeabout his/her treatment session(s) (e.g., comments made to a physician,submitted in response to an automated survey and/or recorded in atreatment diary); the impedance between an earpiece inserted into theear canal of a patient and an electrode affixed to a second locationon/in said patient's body (e.g., an electrode placed in or adjacent tothe patient's other ear canal); the rate at which an earpiece is cooledin response to a cooling stimulus (e.g., data from a temperature sensor,such as thermistor, that monitors how quickly the earpiece cools inresponse to a cooling waveform); the rate at which an earpiece is warmedin response to a warming stimulus (e.g., data from a temperature sensor,such as a thermistor, that monitors how quickly the earpiece warms inresponse to a warming waveform); the rate at which a patient's ear canaland/or inner ear cooled in response to a cooling stimulus (e.g., datafrom a temperature sensor, such as thermistor, that monitors how quicklythe ear canal and/or the inner ear cools in response to a coolingwaveform); the rate at which a patient's ear canal and/or inner earwarmed in response to a warming stimulus (e.g., data from a temperaturesensor, such as a thermistor, that monitors how quickly the ear canaland/or the inner ear warms in response to a warming waveform); patientcomments regarding the subjective fit of one or more earpieces;physician comments regarding the effectiveness of one or more thermalwaveforms and/or physician comments regarding the effect(s) of one ormore waveform modifications.

D. Patient History Database

In some embodiments, the physician support device comprises a patienthistory database configured to receive, transmit and/or store patientinformation.

The patient history database may comprise any suitable type of memoryincluding, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flashmemory, SRAM and DRAM. In some embodiments, the patient history databasecomprises a portable memory device, such as an SD memory card or a USBmemory stick. For example, the patient history database may comprise anSD memory card interface and one or more prescriptions may be stored ona portable SD memory card.

The patient history database may be configured to receive and/ortransmit data from/to any suitable device/module/database, including,but not limited to, modules residing in the physician support device, avestibular stimulation device, a patient control device, a physiciancontrol device, a registry, a TED, a sensor and a portable memory device(e.g., an SD memory card).

The patient history database may be configured to receive and/ortransmit data over any suitable wired or wireless communicationschannel, including, but not limited to, a LAN, the Internet, a publictelephone switching network, Bluetooth, WLAN and the like.

Patient information may comprise any suitable information that isassociated with a patient, including, but not limited to, the patient'smedical history, the patient's current symptoms (if any), the patient'spresent diagnosis (if any), the patient's current prescriptions (if any)and data associated with the delivery of one or more thermal waveformsto the vestibular system and/or the nervous system of the patient.

As will be appreciated by one of skill in the art, the physician supportdevice may comprise any I/O device drivers, including, but not limitedto, software routines accessed through the operating system by theapplications to communicate with devices such as I/O ports, memorycomponents, vestibular stimulation devices, patient control devicesand/or physician control devices.

As will be appreciated by one of skill in the art, the physician supportdevice may be configured (e.g., with computer instructions (i.e.,software)) to operate in a plurality of distinct modes. In each mode,the physician support device may be configured to permit access to somefunctionalities/modules and to prevent access to otherfunctionalities/modules. For example, the physician support device maybe configured to operate in a researcher mode, wherein the user isallowed to perform researcher-oriented tasks, such as generating and/ormodifying the parameters, indications and/or approvals of one or moreidealized thermal waveforms, but is prevented from accessing otherfunctionalities/modules (e.g., the user may be prevented from modifyingthe underlying operational parameters of the physician control device).Similarly, the physician support device may be configured to operate inan engineer mode, wherein the user is allowed to access all of thephysician support device's functionalities/modules. Each mode may beprotected via a unique security measure (e.g., the physician supportdevice may be configured such that each mode is protected by a uniquepassword).

As shown in FIGS. 28-30, in some embodiments of the present invention,the physician support device 4 comprises memory 40, a processor 41 and apower supply 42 (e.g., an internal power supply), wherein memory 40 isrepresentative of the overall hierarchy of memory devices containingsoftware and data used to implement the functionality of the physiciansupport device 4 and wherein the processor 41 communicates with thememory 40 via an address/data bus 400. In particular embodiments, memory40 comprises an operating system 40 a, applications 40 b (e.g., awaveform module 4 a configured to generate and/or modify the parameters,indications and/or approvals of one or more thermal waveforms; atreatment module 4 b configured to generate, modify, update and/orextend a prescription comprising a set of instructions for deliveringone or more thermal waveforms to the vestibular system and/or thenervous system of a patient; a network module 4 d configured to receiveand/or transmit data, a GUI module 4 e configured to display informationand/or accept user input and/or a feedback module 4 f configured toreceive, transmit, and/or analyze data associated with the delivery ofone or more thermal waveforms), data 40 c (e.g., a waveform database 4 hcomprising data associated with the parameters, indications and/orapprovals of one or more thermal waveforms; a prescription database 4 icomprising at least one prescription comprising a set of instructionsfor delivering one or more thermal waveforms to the vestibular systemand/or the nervous system of a patient; a feedback database 4 jcomprising data associated with the delivery of one or more thermalwaveforms and/or a patient history database 4 k comprising patientinformation) and I/O drivers 40 d. In some such embodiments, data 40 ccomprises one or more databases stored on a portable memory device. Forexample, data 40 c may comprise an SD memory card interface and aportable SD memory card comprising a waveform database 4 h, aprescription database 4 i, a feedback database 4 j and/or a patienthistory database 4 k.

In some embodiments, the waveform module 4 a is configured to update thewaveform database 4 h by adding a newly generated idealized thermalwaveform, by modifying one or more of the idealized thermal waveformsstored therein, by deleting one or more of the idealized thermalwaveforms stored therein and/or by modifying the indication/approvalsassociated with one or more of the idealized thermal waveforms storedtherein in response to the analysis of data (e.g., physician feedbackdata) by the feedback module 4 f.

In some embodiments, the network module 4 d is configured to receivedata associated with the parameters, indications and/or approvals of oneor more thermal waveforms from the waveform module 4 a, a patientcontrol device, a physician control device, a registry and/or a portablememory device (e.g., an SD memory card) and to transmit the data to thewaveform database 4 h for storage. In some such embodiments, the data isstored on an SD memory card inserted into an SD memory card interface.

In some embodiments, the network module 4 d is configured to retrievedata associated with the parameters, indications and/or approvals of oneor more thermal waveforms from the waveform database 4 h, a registryand/or a portable memory device (e.g., an SD memory card) and totransmit the data to the waveform module 4 a, the treatment module 4 b,a vestibular stimulation device, a patient control device, a physiciancontrol device, a registry and/or a portable memory device (e.g., an SDmemory card). In some such embodiments, the physician support device isconfigured to transmit all of the idealized thermal waveforms in thewaveform database or a subset thereof (e.g., waveforms indicated for usein the treatment of migraines) to one or more physician control devicesupon request (e.g., after receiving an update request from a physiciancontrol device) or at a specified interval (e.g., every two weeks). Insome preferred embodiments, the physician support device is configuredto replace the idealized thermal waveforms in a physician controldevice's waveform database with the idealized thermal waveforms from thephysician support device's waveform database.

In some embodiments, the network module 4 d is configured to receive oneor more prescriptions from the treatment module 4 b, a patient controldevice, a physician control device, a registry and/or a portable memorydevice (e.g., an SD memory card) and to transmit the prescription(s) tothe prescription database 4 i for storage. In some such embodiments, theprescription(s) is/are stored on an SD memory card inserted into an SDmemory card interface.

In some embodiments, the network module 4 d is configured to retrieveone or more prescriptions from the prescription database 4 i, a registryand/or a portable memory device (e.g., an SD memory card) and totransmit the prescription(s) to the treatment module 4 b, a vestibularstimulation device, a patient control device, a physician controldevice, a registry and/or a portable memory device (e.g., an SD memorycard).

In some embodiments, the network module 4 d is configured to receivedata associated with the delivery of one or more thermal waveforms, dataassociated with the fit of one or more earpieces, patient feedback dataand/or physician feedback data from a vestibular stimulation device, apatient control device, a physician control device, a registry and/or aportable memory device (e.g., an SD memory card) and to transmit thatdata to the feedback database 4 j for storage. In some such embodiments,the data is stored on an SD memory card inserted into an SD memory cardinterface.

In some embodiments, the network module 4 d is configured to retrievedata associated with the delivery of one or more thermal waveforms, dataassociated with the fit of one or more earpieces, patient feedback dataand/or physician feedback data from the feedback database 4 j and totransmit the data to the feedback module 4 f, a physician controldevice, a registry and/or a portable memory device (e.g., an SD memorycard).

In some embodiments, the network module 4 d is configured to receivepatient information from the GUI module 4 e, a vestibular stimulationdevice, a patient control device, a physician control device, a registryand/or a portable memory device (e.g., an SD memory card) and totransmit that data to the patient history database 4 k for storage. Insome such embodiments, the patient information is stored on an SD memorycard inserted into an SD memory card interface.

In some embodiments, the network module 4 d is configured to retrievepatient information from the patient history database 4 k and totransmit the patient information to a physician control device, aregistry and/or a portable memory device (e.g., an SD memory card).

In some embodiments, the feedback module 4 f is configured to analyzedata from the waveform database 4 h, the prescription database 4 i, thefeedback database 4 j and/or the patient history database 4 k toidentify diseases/disorders/injuries for which a given thermal waveform,class of thermal waveforms, combination of thermal waveforms and/ortreatment regimen may be an effective treatment. In some suchembodiments, the feedback module 4 d is configured to automaticallyinitiate such data analysis each time one of the aforementioneddatabases is modified or at a predetermined interval (e.g., every twoweeks). In some such embodiments, the feedback module 4 d is configuredto communicate the results of its analysis to the waveform module 4 a(e.g., by transmitting the results to the waveform module 4 a via thenetwork module 4 d) and/or to a registry.

Registry

As noted above, the present invention provides a registry for receiving,storing and/or transmitting data.

In some embodiments, the registry comprises, consists essentially of orconsists of a network module configured to receive/transmit data and oneor more databases configured to store data.

A registry of the present invention may comprise any suitable computingdevice/system, including, but not limited to, a desktop computer, alaptop computer, a handheld computer, a personal digital assistant(PDA), and a smart phone.

Any conventional security means may be provided to prevent unauthorizedactivation of the registry. For example, the registry may be passwordprotected.

The registry may be configured to receive and/or transmit any suitabledata, including, but not limited to, data associated with theparameters, indications and/or approvals of one or more thermalwaveforms, one or more prescriptions, controller feedback data, dataassociated with the delivery of one or more thermal waveforms, dataassociated with the fit of one or more earpieces, patient feedback data,physician feedback data and/or patient information.

The registry may be configured to receive and/or transmit data from/tovarious devices, including, but not limited to, a vestibular stimulationdevice, a patient control device, a physician control device, aphysician support device and a portable memory device (e.g., an SDmemory card). In some embodiments, the registry is configured to receivedata associated with the parameters, indications and/or approvals of oneor more thermal waveforms (e.g., idealized thermal waveforms) from avestibular stimulation device, a patient control device, a physiciancontrol device, a physician support device, another registry and/or aportable memory device (e.g., an SD memory card); to transmit dataassociated with the parameters, indications and/or approvals of one ormore thermal waveforms (e.g., idealized thermal waveforms) to avestibular stimulation device, a patient control device, a physiciancontrol device, a physician support device, another registry and/or aportable memory device (e.g., an SD memory card); to receive feedbackdata and/or patient information from a vestibular stimulation device, apatient control device, a physician control device, a physician supportdevice, another registry and/or a portable memory device (e.g., an SDmemory card); and/or to transmit feedback data and/or patientinformation to a vestibular stimulation device, a patient controldevice, a physician control device, a physician support device, anotherregistry and/or a portable memory device (e.g., an SD memory card). Insome embodiments, the registry is configured to receive, store and/ortransmit data from/to one or more devices located within a specifiedgeographical region (e.g., one or more physician control devices locatedwithin the United States, one or more physician support devices locatedwithin North America, etc.).

The registry may be configured to receive and/or transmit data over anysuitable wired or wireless communications channel, including, but notlimited to, a LAN, the Internet, a public telephone switching network,Bluetooth, WLAN and the like.

In some embodiments, the registry comprises memory, a processor and apower supply. As will be appreciated by one of skill in the art, theprocessor may be any commercially available or custom microprocessor.Memory can include, but is not limited to, the following types ofdevices: cache, ROM, PROM, EPROM, EEPROM, flash memory, SRAM and DRAM.The power supply may be an internal power supply (e.g., one or morerechargeable batteries that may be recharged without first being removedfrom the registry).

The registry's memory may comprise any suitable software and/or data,including, but not limited to, an operating system, applications, dataand input/output (I/O) drivers.

As will be appreciated by one of skill in the art, the registry may useany suitable operating system, including, but not limited to, OS/2, AIX,OS/390 or System390 from International Business Machines Corp. (Armonk,N.Y.), Window CE, Windows NT, Windows95, Windows98, Windows2000, Windows7 or Windows Vista from Microsoft Corp. (Redmond, Wash.), Mac OS fromApple, Inc. (Cupertino, Calif.), Unix, Linux or Android.

As will be appreciated by one of skill in the art, the registry maycomprise any suitable application, including, but not limited to, one ormore programs configured to implement one or more of the variousfeatures of the present invention. For example, the registry maycomprise a network module configured to receive and/or transmit data, aGUI module configured to display information and/or accept user input,an alert generation module configured to generate one or more alertmessages; a tone generation module configured to produce one or moreaudible tones; a visual indicator module configured to produce one ormore visual indicators and/or a security module configured to preventunauthorized use of the registry.

A. Network Module

In some embodiments, the registry comprises a network module configuredto receive, retrieve and/or transmit data.

The network module may be configured to receive, retrieve and/ortransmit data from/to any suitable device/module/database, including,but not limited to, other modules residing in the registry, databasesresiding in the registry, a vestibular stimulation device, a patientcontrol device, a physician control device, a physician support device,another registry and a portable memory device (e.g., an SD memory card).

The network module may be configured to receive, retrieve and/ortransmit data over any suitable wired or wireless communicationschannel, including, but not limited to, a LAN, the Internet, a publictelephone switching network, Bluetooth, WLAN and the like.

The network module may be configured to receive, retrieve and/ortransmit any suitable data, including, but not limited to, dataassociated with the parameters, indications and/or approvals of one ormore thermal waveforms, one or more prescriptions, controller feedbackdata, data associated with the delivery of one or more thermalwaveforms, data associated with the fit of one or more earpieces,patient feedback data, physician feedback data and/or patientinformation.

In some embodiments, the network module is configured to receive and/orretrieve data associated with the parameters, indications and/orapprovals of one or more thermal waveforms from a waveform databaseresiding in the registry, from a vestibular stimulation device, from apatient control device, from a physician control device, from aphysician support device, from another registry and/or from a portablememory device.

In some embodiments, the network module is configured to receive and/orretrieve one or more prescriptions from a prescription database residingin the registry, from a vestibular stimulation device, from a patientcontrol device, from a physician control device, from a physiciansupport device, from another registry and/or from a portable memorydevice.

In some embodiments, the network module is configured to receive and/orretrieve controller feedback data, data associated with the delivery ofone or more thermal waveforms, data associated with the fit of one ormore earpieces, patient feedback data, physician feedback data and/orpatient information from a feedback database residing in the registry,from a vestibular stimulation device, from a patient control device,from a physician control device, from a physician support device, fromanother registry and/or from a portable memory device.

In some embodiments, the network module is configured to transmit dataassociated with the parameters, indications and/or approvals of one ormore thermal waveforms to a waveform database residing in the registry,to a vestibular stimulation device, to a patient control device, to aphysician control device, to a physician support device, to anotherregistry and/or to a portable memory device.

In some embodiments, the network module is configured to transmit one ormore prescriptions to a prescription database residing in the registry,to a vestibular stimulation device, to a patient control device, to aphysician control device, to a physician support device, to anotherregistry and/or to a portable memory device.

In some embodiments, the network module is configured to transmitcontroller feedback data, data associated with the delivery of one ormore thermal waveforms, data associated with the fit of one or moreearpieces, patient feedback data, physician feedback data and/or patientinformation to a feedback database residing in the registry, to avestibular stimulation device, to a patient control device, to aphysician control device, to a physician support device, to anotherregistry and/or to a portable memory device.

In some embodiments, the network module is configured to access adatabase comprising data associated with the parameters, indicationsand/or approvals of one or more thermal waveforms (e.g., idealizedthermal waveforms). For example, the network module maybe configured toaccess a waveform database residing in a vestibular stimulation device,a waveform database residing in a patient control device, a waveformdatabase residing in a physician control device, a waveform databaseresiding in a physician support device, a waveform database residing inthe registry, a waveform database residing in another registry and/or awaveform database residing in a portable memory device.

In some embodiments, the network module is configured to access adatabase comprising one or more prescriptions. For example, the networkmodule maybe configured to access a prescription database residing in avestibular stimulation device, a prescription database residing in apatient control device, a prescription database residing in a physiciancontrol device, a prescription database residing in a physician supportdevice, a prescription database residing in the registry, a prescriptiondatabase residing in another registry and/or a prescription databaseresiding in a portable memory device.

In some embodiments, the network module is configured to access adatabase comprising controller feedback data, data associated with thedelivery of one or more thermal waveforms, data associated with the fitof one or more earpieces, patient feedback data and/or physicianfeedback data. For example, the network module maybe configured toaccess a feedback database residing in a vestibular stimulation device,a feedback database residing in a patient control device, a feedbackdatabase residing in a physician control device, a feedback databaseresiding in a physician support device, a feedback database residing inthe registry, a feedback database residing in another registry and/or afeedback database residing in a portable memory device.

In some embodiments, the network module is configured to access adatabase comprising patient information. For example, the network modulemaybe configured to access a patient information database residing in avestibular stimulation device, a patient information database residingin a patient control device, a patient information database residing ina physician control device, a patient information database residing in aphysician support device, a patient information database residing in theregistry, a patient information database residing in another registryand/or a patient information database residing in a portable memorydevice.

B. Graphical User Interface Module

In some embodiments, the registry comprises a GUI module configured todisplay information and/or to accept user input. Any suitable GUI may beused, including, but not limited to, a keyboard, a mouse, an LCD displaywith one or more associated entry keys and an interactive touch screen.For example, the GUI may comprise a static pressure touch-sensitivedisplay, a capacitive touch-sensitive display, a resistivetouch-sensitive display, an electrostatic capacity proximity sensor, amagnetic proximity sensor and/or an infrared proximity sensor. See,e.g., U.S. Patent Publication Nos. 2011/0271222, 2011/0273575,2011/0275414 and 2011/0275416.

The GUI module may be configured to display any suitable information,including, but not limited to, data associated with the parameters,indications and/or approvals of one or more thermal waveforms. Forexample, the GUI module may be configured to display one or moreprescribed thermal waveforms; the precise time/temperature parameters ofthe thermal waveform(s) delivered to a patient; the date/time ofdelivery of the thermal waveform(s) delivered to a patient; thetemperature(s) of a patient's ear canal(s) at various time pointsbefore, during and/or after delivery of the thermal waveform(s); thetemperature(s) of a patient's inner ear(s) at various time pointsbefore, during and/or after delivery of the thermal waveform(s); the fitof the earpiece(s) at various time points before, during and/or afterdelivery of the thermal waveform(s); an estimate of the thermal contactbetween the earpiece(s) and the patient's ear canal(s) at various timepoints before, during and/or after delivery of the thermal waveform(s);patient-specific time constants (e.g., a time constant associated withthe transduction of heat from a patient's ear canal to the inner ear);reaction time (i.e., how long it took for a patient to react to one ormore thermal waveforms); the effectiveness of one or more thermalwaveforms (i.e., whether and to what extent symptoms were relieved,whether the thermal waveform(s) enhanced the effectiveness of anotheragent/therapy, etc.); the stability of a treatment (i.e., how long theeffects of the treatment lasted); the instability of a treatment (i.e.,which symptom(s) returned and when did it/they return); the presence orabsence of comorbid disorders, injuries and/or diseases; disorder,injury and/or disease modulation(s) and/or modification(s) that occurredas a result of treatment; the cognitive effect(s) of one or more thermalwaveforms; patient compliance (e.g., whether a patient initiateddelivery at the prescribed time, whether a patient completed theprescribed treatment session, whether the earpiece(s) remained properlyfitted in a patient's ear canal(s) for the duration of the treatmentsession, etc.); the mood of a patient at various time points before,during and/or after delivery of one or more thermal waveforms (e.g.,videos/images of a patient that may be used to assess mood); objectivesmeasures of efficacy (e.g., nystamography data, EEG data, MRI data,heart rate data, blood pressure data); subjective measures of efficacy(e.g., a patient-reported pain score); blood chemistry data (e.g., bloodA1c levels, blood glucose levels and blood cortisol levels); salivachemistry data (e.g., saliva cortisol levels); urine chemistry data(e.g., urine cortisol levels)), comments a patient made about his/hertreatment session(s) (e.g., comments made to a physician, submitted inresponse to an automated survey and/or recorded in a treatment diary);the impedance between an earpiece inserted into the ear canal of apatient and an electrode affixed to a second location on/in saidpatient's body (e.g., an electrode placed in or adjacent to thepatient's other ear canal); the rate at which a patient's inner earcools in response to a cooling stimulus (e.g., data from a temperaturesensor, such as thermistor, that monitors how quickly the inner earcools in response to a cooling waveform); the rate at which a patient'sinner ear warms in response to a warming stimulus (e.g., data from atemperature sensor, such as thermistor, that monitors how quickly theinner ear warms in response to a warming waveform); patient commentsregarding the subjective fit of his/her earpiece(s); physician commentsregarding the effectiveness of one or more thermal waveforms and/orphysician comments regarding the effect(s) of one or more waveformmodifications.

The GUI module may be configured to accept any suitable user input,including, but not limited to, instructions for transmitting theparameters, indications and/or approvals of a thermal waveforms to oneor more vestibular stimulation devices, one or more patient controldevices, one or more physician control devices and/or one or morephysician support devices.

C. Alert Generation Module

In some embodiments, the registry comprises an alert generation moduleconfigured to generate one or more alert messages.

The alert generation module may be configured to generate any suitablealert message, including, but not limited to, an alert indicating thatdata has been received and an alert indicating that a request for datahas been received.

In some embodiments, the alert generation module is configured tocommunicate with various devices/modules, including, but not limited to,a vestibular stimulation device, a patient control device, a physiciancontrol device, a physician support device, another regsitry, a portablememory device (e.g., an SD memory card) and other modules of theregistry. For example, the alert generation module may be configured toprovide instructions to the GUI module and/or the tone generation modulefor displaying one or more alert messages and/or for generation anaudible tone to alert a user of the presence of the one or more alertmessages. The graphical user interface module may be configured todisplay the one or more alert messages immediately upon generation orupon interaction with a user (e.g., an alert notification icon may begenerated, with the alert message being displayed only after the userindicates that he/she wishes to view the message).

D. Tone Generation Module

In some embodiments, the registry comprises a tone generation moduleconfigured to produce audible tones. In some such embodiments, the tonegeneration module comprises a piezo buzzer. Audible tones may beproduced to alert a user to various circumstances/events, including, butnot limited to, the existence of an unread/unviewed alert message.Audible tones may be generated repeatedly in response to a singlecircumstance/event (e.g., an audible tone may be generated repeatedlyuntil the user views/reads the message) and may become progressivelylouder and/or more frequent with time.

E. Visual Indicator Module

In some embodiments, the registry comprises a visual indicator moduleconfigured to notify a user of the existence of an unread/unviewed alertmessage. In some such embodiments, the visual indicator module comprisesan LED indicator light. The visual indicator module may be activatedrepeatedly in response to a single alert message (e.g., an LED light maybe illuminated repeatedly until the user views/reads the message) or mayremain activated until the user views/reads the message.

F. Security Module

In some embodiments, the registry comprises a security module configuredto prevent unauthorized use of the registry (i.e., to preventunauthorized persons from using the registry, to prevent authorizedpersons from using the registry in an unauthorized manner, etc.).

The security module may be configured to prevent unauthorized use of theregistry using any suitable means of security, including, but notlimited to, password protection and data encryption. For example, thesecurity module may be configured such that a user is required to inputa designated password prior to accessing the waveform database;entering/viewing patient feedback data; entering/viewing physicianfeedback data and/or entering/viewing patient information (as discussedabove with respect to FIG. 12).

As will be appreciated by one of skill in the art, the registry maycomprise any suitable data, including, but not limited to, static and/ordynamic data used by the operating system, applications, I/O devicedrivers and other software components, controller feedback data, dataassociated with the parameters, indications and/or approvals of one ormore thermal waveforms (e.g., idealized thermal waveforms), dataassociated with one or more prescriptions, data associated with thedelivery of one or more thermal waveforms, data associated with the fitof one or more earpieces, patient feedback data, physician feedback dataand patient information. For example, the registry may comprise awaveform database comprising data associated with one or more idealizedthermal waveforms; a prescription database comprising data associatedwith one or more prescriptions; a feedback database comprisingcontroller feedback data, data associated with the delivery of one ormore thermal waveforms to the vestibular system and/or the nervoussystem of a patient, patient feedback data and physician feedback dataand/or a patient history database comprising data associated with one ormore patients. In some embodiments, two or more of the aforementioneddatabases are combined to form a single database comprising data fromeach of the individual databases (e.g., the registry may comprise afeedback-history database comprising data associated with the deliveryof one or more thermal waveforms and patient information). In someembodiments, one of the aforementioned databases is split into two ormore distinct databases (e.g., the registry may comprise a deliveryfeedback database comprising data associated with the specificparameters of the thermal waveform(s) delivered to a patient, a patientfeedback database comprising patient feedback data and a physicianfeedback database comprising physician feedback data). In someembodiments, one or more of the data types described below with respectto one of the databases described below is stored in one of the otherdatabases described below (e.g., the patient information database,rather than the feedback database, may be configured to receive/storepatient feedback data). In some embodiments, data is transmitted,received and/or stored in a controlled format (e.g., in a standardizedformat using forms/programs supplied by a physician support device or aregistry). The registry may be configured to transmit, receive and storedata in a manner that ensures compliance with any and all applicablelaws and/or regulations (e.g., the Health Insurance Portability andAccountability Act of 1996 (P.L. 104-191; “HIPAA”)).

A. Waveform Database

In some embodiments, the registry comprises a waveform databaseconfigured to receive, store and/or transmit data associated with theparameters, indications and/or approvals of one or more thermalwaveforms (e.g, one or more idealized thermal waveforms). In some suchembodiments, the waveform database is configured such that one or moreof the thermal waveforms stored therein is/are protected (e.g., usersmay be prevented from modifying and/or deleting the idealized thermalwaveform(s) stored in the waveform database).

The waveform database may comprise any suitable type of memoryincluding, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flashmemory, SRAM and DRAM. In some embodiments, the waveform databasecomprises a portable memory device, such as an SD memory card or a USBmemory stick. For example, the waveform database may comprise an SDmemory card interface and one or more prescriptions may be stored on aportable SD memory card.

The waveform database may be configured to receive and/or transmit datafrom/to any suitable device/module/database, including, but not limitedto, modules residing in the registry, a vestibular stimulation device, apatient control device, a physician control device, a physician supportdevice, another registry and a portable memory device (e.g., an SDmemory card).

In some embodiments, the registry is configured to receive, store and/ortransmit data associated with the parameters, indications and/orapprovals of one or more thermal waveforms (e.g, one or more idealizedthermal waveforms) from/to one or more devices located within aspecified geographical region. For example, the waveform database may beconfigured to receive, store and/or transmit data associated with theparameters, indications and/or approvals of one or more idealized,actively controlled, time-varying thermal waveforms from/to one or morephysician control devices and/or one or more physician support deviceslocated within a specified geographical region (e.g., the northeasternUnited States, the southeastern United States, the United States, NorthAmerica, Europe, Japan, China, etc.).

The waveform database may be configured to receive and/or transmit dataover any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like.

B. Prescription Database

In some embodiments, the registry comprises a prescription databaseconfigured to receive, transmit and/or store one or more prescriptions,wherein each prescription comprising a set of instructions fordelivering one or more thermal waveforms to the vestibular system and/orthe nervous system of a patient.

The prescription database may comprise any suitable type of memoryincluding, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flashmemory, SRAM and DRAM. In some embodiments, the prescription databasecomprises a portable memory device, such as an SD memory card or a USBmemory stick. For example, the prescription database may comprise an SDmemory card interface and one or more prescriptions may be stored on aportable SD memory card.

The prescription database may be configured to receive and/or transmitdata from/to any suitable device/module/database, including, but notlimited to, modules residing in the registry, a vestibular stimulationdevice, a patient control device, a physician control device, aphysician support device, another registry and a portable memory device(e.g., an SD memory card).

In some embodiments, the registry is configured to receive, store and/ortransmit data associated with one or more prescriptions from/to one ormore devices located within a specified geographical region. Forexample, the prescription database may be configured to receive, storeand/or transmit data associated with one or more prescriptions from/toone or more physician control devices and/or one or more physiciansupport devices located within a specified geographical region (e.g.,the northeastern United States, the southeastern United States, theUnited States, North America, Europe, Japan, China, etc.).

The prescription database may be configured to receive and/or transmitdata over any suitable wired or wireless communications channel,including, but not limited to, a LAN, the Internet, a public telephoneswitching network, Bluetooth, WLAN and the like.

C. Feedback Database

In some embodiments, the registry comprises a feedback databaseconfigured to receive, transmit and/or store feedback data.

The feedback database may comprise any suitable type of memoryincluding, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flashmemory, SRAM and DRAM. In some embodiments, the feedback databasecomprises a portable memory device, such as an SD memory card or a USBmemory stick. For example, the feedback database may comprise an SDmemory card interface and one or more prescriptions may be stored on aportable SD memory card.

The feedback database may be configured to receive and/or transmitfeedback data from/to any suitable device/module/database, including,but not limited to, modules residing in the physician support device, avestibular stimulation device, a patient control device, a physiciancontrol device, a physician support device, another registry and aportable memory device (e.g., an SD memory card).

In some embodiments, the registry is configured to receive, store and/ortransmit feedback data from/to one or more devices located within aspecified geographical region. For example, the feedback database may beconfigured to receive, store and/or transmit feedback from/to one ormore physician control devices and/or one or more physician supportdevices located within a specified geographical region (e.g., thenortheastern United States, the southeastern United States, the UnitedStates, North America, Europe, Japan, China, etc.).

The feedback database may be configured to receive and/or transmit dataover any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like.

Feedback data may comprise any suitable data, including, but not limitedto, controller feedback data, data associated with the delivery of oneor more thermal waveforms, data associated with the fit of one or moreearpieces, patient feedback data, physician feedback data and/or patientinformation. For example, the feedback database may comprise a log filedetailing the target time/temperature parameters of one or moreprescribed thermal waveform(s); the time/temperature parameters of thethermal waveform(s) delivered to a patient; the date/time of delivery ofthe thermal waveform(s) delivered to a patient; the temperature(s) of apatient's ear canal(s) at various time points before, during and/orafter delivery of one or more thermal waveforms; the temperature(s) of apatient's inner ear(s) at various time points before, during and/orafter delivery of one or more thermal waveforms; the fit of one or moreearpieces at various time points before, during and/or after delivery ofone or more thermal waveforms; an estimate of the thermal contactbetween one or more earpieces and a patient's ear canal(s) at varioustime points before, during and/or after delivery of one or more thermalwaveforms; patient-specific time constants (e.g., a time constantassociated with the transduction of heat from a patient's ear canal tothe inner ear); a patient's reaction time (i.e., how long it took for apatient to react to one or more thermal waveforms); effectiveness of oneor more thermal waveforms (i.e., whether and to what extent symptomswere relieved, whether the thermal waveform(s) enhanced theeffectiveness of another agent/therapy, etc.); stability of a treatment(i.e., how long the effects of a treatment lasted); instability of atreatment (i.e., which symptom(s) returned and when did it/they return);the presence or absence of comorbid disorders, injuries and/or diseases;disorder, injury and/or disease modulation(s) and/or modification(s)that occurred as a result of treatment; the cognitive effect(s) of oneor more thermal waveforms; patient compliance (e.g., whether a patientinitiated delivery at the prescribed time, whether a patient completedthe prescribed treatment session, whether the earpiece(s) remainedproperly fitted in a patient's ear canal(s) for the duration of thetreatment session, etc.); the mood of a patient at various time pointsbefore, during and/or after delivery of one or more thermal waveforms(e.g., videos/images of a patient that may be used to assess mood);objectives measures of efficacy (e.g., nystamography data, EEG data, MRIdata, heart rate data, blood pressure data); subjective measures ofefficacy (e.g., a patient-reported pain score); blood chemistry data(e.g., blood A1c levels, blood glucose levels and blood cortisollevels); saliva chemistry data (e.g., saliva cortisol levels); urinechemistry data (e.g., urine cortisol levels)); comments a patient madeabout his/her treatment session(s) (e.g., comments made to a physician,submitted in response to an automated survey and/or recorded in atreatment diary); the impedance between an earpiece inserted into theear canal of a patient and an electrode affixed to a second locationon/in said patient's body (e.g., an electrode placed in or adjacent tothe patient's other ear canal); the rate at which an earpiece is cooledin response to a cooling stimulus (e.g., data from a temperature sensor,such as thermistor, that monitors how quickly the earpiece cools inresponse to a cooling waveform); the rate at which an earpiece is warmedin response to a warming stimulus (e.g., data from a temperature sensor,such as a thermistor, that monitors how quickly the earpiece warms inresponse to a warming waveform); the rate at which a patient's ear canaland/or inner ear cooled in response to a cooling stimulus (e.g., datafrom a temperature sensor, such as thermistor, that monitors how quicklythe ear canal and/or the inner ear cools in response to a coolingwaveform); the rate at which a patient's ear canal and/or inner earwarmed in response to a warming stimulus (e.g., data from a temperaturesensor, such as a thermistor, that monitors how quickly the ear canaland/or the inner ear warms in response to a warming waveform); patientcomments regarding the subjective fit of one or more earpieces;physician comments regarding the effectiveness of one or more thermalwaveforms and/or physician comments regarding the effect(s) of one ormore waveform modifications.

D. Patient History Database

In some embodiments, the registry comprises a patient history databaseconfigured to receive, transmit and/or store patient information.

The patient history database may comprise any suitable type of memoryincluding, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flashmemory, SRAM and DRAM. In some embodiments, the patient history databasecomprises a portable memory device, such as an SD memory card or a USBmemory stick. For example, the patient history database may comprise anSD memory card interface and one or more prescriptions may be stored ona portable SD memory card.

The patient history database may be configured to receive and/ortransmit data from/to any suitable device/module/database, including,but not limited to, modules residing in the registry, a vestibularstimulation device, a patient control device, a physician controldevice, a physician support device, another registry and a portablememory device (e.g., an SD memory card).

In some embodiments, the registry is configured to receive, store and/ortransmit patient information from/to one or more devices located withina specified geographical region. For example, the patient historydatabase may be configured to receive, store and/or transmit patientinformation from/to one or more physician control devices and/or one ormore physician support devices located within a specified geographicalregion (e.g., the northeastern United States, the southeastern UnitedStates, the United States, North America, Europe, Japan, China, etc.).

The patient history database may be configured to receive and/ortransmit data over any suitable wired or wireless communicationschannel, including, but not limited to, a LAN, the Internet, a publictelephone switching network, Bluetooth, WLAN and the like.

Patient information may comprise any suitable information that isassociated with a patient, including, but not limited to, the patient'smedical history, the patient's current symptoms (if any), the patient'spresent diagnosis (if any), the patient's current prescriptions (if any)and data associated with the delivery of one or more thermal waveformsto the vestibular system and/or the nervous system of the patient.

As will be appreciated by one of skill in the art, the registry maycomprise any I/O device drivers, including, but not limited to, softwareroutines accessed through the operating system by the applications tocommunicate with devices such as I/O ports, memory components,vestibular stimulation devices, patient control devices, physiciancontrol devices and/or physician support devices.

As will be appreciated by one of skill in the art, the registry may beconfigured (e.g., with computer instructions (i.e., software)) tooperate in a plurality of distinct modes. In each mode, the registry maybe configured to permit access to some functionalities/modules and toprevent access to other functionalities/modules. For example, theregistry may be configured to operate in a researcher mode, wherein theuser is allowed to perform researcher-oriented tasks, such as uploadingand/or downloading data associated with the parameters, indicationand/or approvals of one or more idealized thermal waveforms, but isprevented from accessing other functionalities/modules (e.g., the usermay be prevented from modifying the underlying operational parameters ofthe registry). Similarly, the registry may be configured to operate inan engineer mode, wherein the user is allowed to access all of theregistry's functionalities/modules. Each mode may be protected via aunique security measure (e.g., the registry may be configured such thateach mode is protected by a unique password).

As shown in FIGS. 31-32, in some embodiments of the present invention,the registry 5 comprises memory 50, a processor 51 and a power supply 52(e.g., an internal power supply), wherein memory 50 is representative ofthe overall hierarchy of memory devices containing software and dataused to implement the functionality of the registry 5 and wherein theprocessor 51 communicates with the memory 50 via an address/data bus500. In particular embodiments, memory 50 comprises an operating system50 a, applications 50 b (e.g., a network module 5 d configured toreceive and/or transmit data and/or a GUI module 5 e configured todisplay information and/or accept user input), data 50 c (e.g., awaveform database 5 h comprising data associated with the parameters,indications and/or approvals of one or more thermal waveforms; aprescription database 5 i comprising at least one prescriptioncomprising a set of instructions for delivering one or more thermalwaveforms to the vestibular system and/or the nervous system of apatient; a feedback database 5 j comprising data associated with thedelivery of one or more thermal waveforms and/or a patient historydatabase 5 k comprising patient information) and I/O drivers 50 d. Insome such embodiments, data 50 c comprises one or more databases storedon a portable memory device. For example, data 50 c may comprise an SDmemory card interface and a portable SD memory card comprising awaveform database 5 h, a prescription database 5 i, a feedback database5 j and/or a patient history database 5 k.

In some embodiments, the network module 5 d is configured to receivedata associated with the parameters, indications and/or approvals of oneor more thermal waveforms from a vestibular stimulation device, apatient control device, a physician control device, a physician supportdevice, another registry and/or a portable memory device (e.g., an SDmemory card) and to transmit the data to the waveform database 5 h forstorage. For example, the network module 5 d may be configured toreceive data associated with the parameters, indications and/orapprovals of one or more idealized, actively controlled, time-varyingthermal waveforms from one or more physician control devices and/or oneor more physician support devices located in a specified geographicalregion (e.g., the northeastern United States, the southeastern UnitedStates, the United States, North America, Europe, Japan, China, etc.).

In some embodiments, the network module 5 d is configured to retrievedata associated with the parameters, indications and/or approvals of oneor more thermal waveforms from the waveform database 5 h and to transmitthe data to a vestibular stimulation device, a patient control device, aphysician control device, a physician support device, another registryand/or a portable memory device (e.g., an SD memory card). For example,the network module 5 d may be configured to transmit data associatedwith the parameters, indications and/or approvals of one or more thermalwaveforms from the waveform database 5 h to one or more physiciancontrol devices and/or one or more physician support devices located ina specified geographical region (e.g., the northeastern United States,the southeastern United States, the United States, North America,Europe, Japan, China, etc.). In some such embodiments, the physiciansupport device is configured to transmit all of the idealized thermalwaveforms in the waveform database or a subset thereof (e.g., waveformsindicated for use in the treatment of migraines) to one or morephysician control devices and/or one or more physician support devicesupon request (e.g., after receiving an update request from a physiciansupport device) or at a specified interval (e.g., every two weeks).

In some embodiments, the registry is configured to replace the idealizedthermal waveforms in a physician support device's waveform database withthe idealized thermal waveforms from the registry's waveform database.For example, the network module 5 d may be configured to update thewaveform database(s) of one or more physician control devices and/or oneor more physician support devices located in a specified geographicalregion (e.g., the northeastern United States, the southeastern UnitedStates, the United States, North America, Europe, Japan, China, etc.) byreplacing the idealized thermal waveforms located therein with idealizedthermal waveforms from the registry's waveform database.

In some embodiments, the network module 5 d is configured to receive oneor more prescriptions from a vestibular stimulation device, a patientcontrol device, a physician control device, a physician support device,another registry and/or a portable memory device (e.g., an SD memorycard) and to transmit the prescription(s) to the prescription database 5i for storage. For example, the network module 5 d may be configured toreceive data associated with one or more prescriptions from one or morephysician control devices and/or one or more physician support deviceslocated in a specified geographical region (e.g., the northeasternUnited States, the southeastern United States, the United States, NorthAmerica, Europe, Japan, China, etc.).

In some embodiments, the network module 5 d is configured to retrieveone or more prescriptions from the prescription database 5 i and totransmit the prescription(s) to a vestibular stimulation device, apatient control device, a physician control device, a physician supportdevice, another registry and/or a portable memory device (e.g., an SDmemory card). For example, the network module 5 d may be configured totransmit data associated with one or more prescriptions from theperspiration database 5 i to one or more physician control devicesand/or one or more physician support devices located in a specifiedgeographical region (e.g., the northeastern United States, thesoutheastern United States, the United States, North America, Europe,Japan, China, etc.).

In some embodiments, the network module 5 d is configured to receivedata associated with the delivery of one or more thermal waveforms, dataassociated with the fit of one or more earpieces, patient feedback dataand/or physician feedback data from a vestibular stimulation device, apatient control device, a physician control device, a physician supportdevice, another registry and/or a portable memory device (e.g., an SDmemory card) and to transmit that data to the feedback database 5 j forstorage. For example, the network module 5 d may be configured toreceive data associated with the delivery of one or more thermalwaveforms, data associated with the fit of one or more earpieces,patient feedback data and/or physician feedback data from one or morephysician control devices and/or one or more physician support deviceslocated in a specified geographical region (e.g., the northeasternUnited States, the southeastern United States, the United States, NorthAmerica, Europe, Japan, China, etc.).

In some embodiments, the network module 5 d is configured to retrievedata associated with the delivery of one or more thermal waveforms, dataassociated with the fit of one or more earpieces, patient feedback dataand/or physician feedback data from the feedback database 5 j and totransmit the data to a vestibular stimulation device, a patient controldevice, a physician control device, a physician support device, anotherregistry and/or a portable memory device (e.g., an SD memory card). Forexample, the network module 5 d may be configured to transmit dataassociated with the delivery of one or more thermal waveforms, dataassociated with the fit of one or more earpieces, patient feedback dataand/or physician feedback data from the feedback database 5 j to one ormore physician control devices and/or one or more physician supportdevices located in a specified geographical region (e.g., thenortheastern United States, the southeastern United States, the UnitedStates, North America, Europe, Japan, China, etc.).

In some embodiments, the network module 5 d is configured to receivepatient information from a vestibular stimulation device, a patientcontrol device, a physician control device, a physician support device,another registry and/or a portable memory device (e.g., an SD memorycard) and to transmit that data to the patient history database 5 k forstorage. For example, the network module 5 d may be configured toreceive patient information from one or more physician control devicesand/or one or more physician support devices located in a specifiedgeographical region (e.g., the northeastern United States, thesoutheastern United States, the United States, North America, Europe,Japan, China, etc.).

In some embodiments, the network module 5 d is configured to retrievepatient information from the patient history database 5 k and totransmit the patient information to a a vestibular stimulation device, apatient control device, a physician control device, a physician supportdevice, another registry and/or a portable memory device (e.g., an SDmemory card). For example, the network module 5 d may be configured totransmit patient information from the patient history database 5 k toone or more physician control devices and/or one or more physiciansupport devices located in a specified geographical region (e.g., thenortheastern United States, the southeastern United States, the UnitedStates, North America, Europe, Japan, China, etc.).

Telemedicine Module

As noted above, the present invention provides a telemedicine module forfacilitating and/or controlling communications between vestibularstimulation devices, patient control devices, physician control devices,physician support devices and/or registries.

In some embodiments, the telemedicine module is configured to facilitateand/or control communications between a vestibular stimulation device, apatient control device, a physician control device, a physician supportdevice and/or a registry by ensuring that data is transmitted betweenthe devices in a manner that complies with any and all applicable lawsand/or regulations (e.g., the Health Insurance Portability andAccountability Act of 1996 (P.L. 104-191; “HIPAA”)).

The telemedicine module may facilitate and/or control communicationssent over any suitable wired or wireless communications channel,including, but not limited to, a LAN, the Internet, a public telephoneswitching network, Bluetooth, WLAN and the like.

Vestibular Stimulation System

As noted above, the present invention provides a vestibular stimulationsystem for delivering one or more thermal waveforms (e.g., one or moreactively controlled, time-varying thermal waveforms) to the vestibularsystem and/or the nervous system of a patient.

The vestibular stimulation system may comprise, consist essentially ofor consist of a vestibular stimulation device and a physician controldevice (as shown in FIGS. 33, 35-36, 38-39, 41-42 and 44). In someembodiments, the vestibular stimulation system comprises, consistsessentially of or consists of a physician control device and a pluralityof vestibular stimulation devices (as shown in FIGS. 34, 37 and 40). Insome embodiments, the vestibular stimulation system comprises aplurality of physician control devices and a plurality of vestibularstimulation devices 1 (as shown in FIGS. 40 and 43). Any suitablevestibular stimulation device(s) and physician control device(s) may beused, including, but not limited to, those described above.

The vestibular stimulation system may further comprise a patient controldevice (as shown in FIGS. 36 and 38). In some embodiments, thevestibular stimulation system comprises a plurality of patient controldevices (as shown in FIG. 37). Any suitable patient control device(s)may be used, including, but not limited to, those described above.

The vestibular stimulation system may further comprise a physiciansupport device (as shown in FIGS. 39-42). In some embodiments, thevestibular stimulation system comprises a plurality of physician supportdevices. Any suitable physician support device(s) may be used,including, but not limited to, those described above.

The vestibular stimulation system may further comprise a registry (asshown in FIGS. 42-44). In some embodiments, the vestibular stimulationsystem comprises a plurality of registries. Any suitable registry (orregistries) may be used, including, but not limited to, those describedabove.

As shown in FIG. 33, the vestibular stimulation system may comprise,consist essentially of or consist of a vestibular stimulation device 1operatively connected to a physician control device 2.

The physician control device 2 may be configured to generate one or morethermal waveforms (i.e., to generate the parameters, indications and/orapprovals of one or more thermal waveforms) and/or to store the thermalwaveform(s) in a database (e.g., to store the parameters, indicationsand/or approvals of the thermal waveform(s) in a waveform database asdescribed above).

The physician control device 2 may be configured to generate one or moreprescriptions. Each prescription may comprise, consist essentially of orconsist of a set of instructions for delivering one or more thermalwaveforms to the vestibular system and/or the nervous system of apatient. In such embodiments, the prescription may comprise a set ofinstructions for delivering one or more of the thermal waveformsgenerated by the physician control device 2 to the vestibular systemand/or the nervous system of a patient.

The physician control device 2 may be configured to store one or moreprescriptions in a database residing therein (e.g., a prescriptiondatabase as described above) and/or to relay one or more prescriptionsto the vestibular stimulation device 1. The physician control device 2may be configured to transmit one or more prescriptions to thevestibular stimulation device 1 over any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN, theInternet, a public telephone switching network, Bluetooth, WLAN and thelike. Likewise, the vestibular stimulation device 1 may be configured toaccess a prescription database residing in the physician control device2 and to retrieve one or more prescriptions using any suitable wired orwireless communications channel, including, but not limited to, a LAN,the Internet, a public telephone switching network, Bluetooth, WLAN andthe like. Alternatively, one or more prescriptions may be transferred tothe vestibular stimulation device 1 using a portable memory device, suchas an SD memory card or a USB memory stick.

The vestibular stimulation device 1 may be configured to deliver one ormore prescribed thermal waveforms to the vestibular system and/or thenervous system of a patient. For example, as described above, thevestibular stimulation device 1 may be configured to deliver theprescribed thermal waveform(s) the vestibular system and/or the nervoussystem of the patient by activating one or more TEDs to warm and/or coolan earpiece inserted into an ear canal of the patient.

The vestibular stimulation device 1 may be configured to generatefeedback data. For example, the vestibular stimulation device 1 maycomprise one or more sensors as described above, which may generatefeedback data responsive to delivering the prescribed thermalwaveform(s) to the vestibular system and/or the nervous system of thepatient. Similarly, the vestibular stimulation device 1 may comprise aGUI configured generate feedback data (e.g., patient feedback data)responsive to user input.

The vestibular stimulation device 1 may be configured to store feedbackdata in a database residing therein (e.g., a feedback database asdescribed above) and/or to relay feedback data to the physician controldevice 2. The vestibular stimulation device 1 may be configured totransmit feedback data to the physician control device 2 over anysuitable wired or wireless communications channel, including, but notlimited to, a LAN, the Internet, a public telephone switching network,Bluetooth, WLAN and the like. Likewise, the physician control device 2may be configured to access a feedback database residing in thevestibular stimulation device 1 and to retrieve feedback data using anysuitable wired or wireless communications channel, including, but notlimited to, a LAN, the Internet, a public telephone switching network,Bluetooth, WLAN and the like. Alternatively, feedback data may betransferred to the physician control device 2 using a portable memorydevice, such as an SD memory card or a USB memory stick.

The physician control device 2 may be configured to analyze feedbackdata received and/or retrieved from the vestibular stimulation device 1.For example, the physician control device 2 may be configured to use thefeedback data to estimate the thermal contact between one or moreearpiece and the patient's ear canal(s), to calculate patient-specifictime constants, to evaluate the precision with the prescribed thermalwaveform(s) was/were delivered, etc.

The physician control device 2 may be configured to modify one or morethermal waveforms responsive to analyzing feedback data received and/orretrieved from the vestibular stimulation device 1. For example, thephysician control device 2 may be configured to modify one or moreparameters of a thermal waveform generated by the physician controldevice 2 and/or stored in a waveform database residing therein. Thephysician control device 2 may be configured to modify the thermalwaveform(s) automatically (e.g., the physician control device 2 may beconfigured to automatically modify one or more thermal waveforms if/whenany of its analyses indicate that such modifications are likely toimprove the efficacy of the thermal waveform(s)) or responsive to userinput.

The physician control device 2 may be configured to store one or moremodified thermal waveforms in a database residing therein (e.g., awaveform database as described above) and/or to relay the modifiedthermal waveform(s) to the vestibular stimulation device 1. Thephysician control device 2 may be configured to transmit one or moremodified thermal waveforms to the vestibular stimulation device 1 overany suitable wired or wireless communications channel, including, butnot limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like. Likewise, the vestibularstimulation device 1 may be configured to access a waveform databaseresiding in the physician control device 2 and to retrieve the modifiedthermal waveform(s) using any suitable wired or wireless communicationschannel, including, but not limited to, a LAN, the Internet, a publictelephone switching network, Bluetooth, WLAN and the like.Alternatively, the modified thermal waveform(s) may be transferred tothe vestibular stimulation device 1 using a portable memory device, suchas an SD memory card or a USB memory stick.

The physician control device 2 may be configured to modify one or moreprescriptions responsive to analyzing feedback data received and/orretrieved from the vestibular stimulation device 1. For example, thephysician control device 2 may be configured to modify one or moreparameters of a prescription generated by the physician control device 2and/or stored in a prescription database residing therein. The physiciancontrol device 2 may be configured to modify the prescription(s)automatically (e.g., the physician control device 2 may be configured toautomatically modify one or more prescriptions if/when any of itsanalyses indicate that such modifications are likely to improve theefficacy of the prescription(s)) or responsive to user input.

The physician control device 2 may be configured to store one or moremodified prescriptions in a database residing therein (e.g., a waveformdatabase as described above) and/or to relay the modified thermalwaveform(s) to the vestibular stimulation device 1. The physiciancontrol device 2 may be configured to transmit one or more modifiedprescriptions to the vestibular stimulation device 1 over any suitablewired or wireless communications channel, including, but not limited to,a LAN, the Internet, a public telephone switching network, Bluetooth,WLAN and the like. Likewise, the vestibular stimulation device 1 may beconfigured to access a prescription database residing in the physiciancontrol device 2 and to retrieve the modified prescription(s) using anysuitable wired or wireless communications channel, including, but notlimited to, a LAN, the Internet, a public telephone switching network,Bluetooth, WLAN and the like. Alternatively, the modifiedprescription(s) may be transferred to the vestibular stimulation device1 using a portable memory device, such as an SD memory card or a USBmemory stick.

The vestibular stimulation device 1 may be configured to deliver one ormore thermal waveforms to the vestibular system and/or the nervoussystem of the patient in accordance with one or more modifiedprescriptions to the vestibular system and/or the nervous system of apatient. For example, as described above, the vestibular stimulationdevice 1 may be configured to deliver the prescribed thermal waveform(s)the vestibular system and/or the nervous system of the patient byactivating one or more TEDs to warm and/or cool an earpiece insertedinto an ear canal of the patient.

The physician control device 2 may be configured to generate one or moresoftware updates. Each software update may comprise, consist essentiallyof or consist of a set of instructions for modifying one or moreoperational parameters of the vestibular stimulation device 1.

The physician control device 2 may be configured to store one or moresoftware updates in a database residing therein and/or to relay one ormore software updates to the vestibular stimulation device 1. Thephysician control device 2 may be configured to transmit one or moresoftware updates to the vestibular stimulation device 1 over anysuitable wired or wireless communications channel, including, but notlimited to, a LAN, the Internet, a public telephone switching network,Bluetooth, WLAN and the like. Likewise, the vestibular stimulationdevice 1 may be configured to access a database residing in thephysician control device 2 and to retrieve one or more software updatesusing any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like. Alternatively, one or moresoftware updates may be transferred to the vestibular stimulation device1 using a portable memory device, such as an SD memory card or a USBmemory stick. The software update(s) may be relayed from the physiciancontrol device 2 to the vestibular stimulation device 1 automatically(e.g., upon generation, once per week, once per month, etc.) or inresponse to user input.

The vestibular stimulation device 1 may be configured to modify one ormore of its operational parameters responsive to receiving and/orretrieving one or more software updates from the physician controldevice 2. The vestibular stimulation device 1 may be configured tomodify one or more of its operational parameters automatically ((e.g.,upon receipt of the software update(s), once per week, once per month,etc.) or in response to user input.

As shown in FIG. 34, the vestibular stimulation system may comprise,consist essentially of or consist of a physician control device 2operatively connected to a plurality of vestibular stimulation devices 1a, 1 b, 1 c, 1 d.

The physician control device 2 may be configured to generate one or morethermal waveforms (i.e., to generate the parameters, indications and/orapprovals of one or more thermal waveforms) and/or to store the thermalwaveform(s) in a database (e.g., to store the parameters, indicationsand/or approvals of the thermal waveform(s) in a waveform database asdescribed above).

The physician control device 2 may be configured to generate a pluralityof prescriptions, each comprising a set of instructions for deliveringone or more thermal waveforms to the vestibular system and/or thenervous system of a patient. In such embodiments, one or more of theprescriptions may comprise a set of instructions for delivering one ormore of the thermal waveforms generated by the physician control device2 to the vestibular system and/or the nervous system of a patient.

The physician control device 2 may be configured to store theprescriptions in a database residing therein (e.g., a prescriptiondatabase as described above) and/or to relay each prescription to avestibular stimulation device 1 a, 1 b, 1 c, 1 d associated with thepatient for whom the prescription was generated. The physician controldevice 2 may be configured to transmit the prescriptions to thevestibular stimulation devices 1 a, 1 b, 1 c, 1 d over any suitablewired or wireless communications channel, including, but not limited to,a LAN, the Internet, a public telephone switching network, Bluetooth,WLAN and the like. Likewise, each of the vestibular stimulation devices1 a, 1 b, 1 c, 1 d may be configured to access a prescription databaseresiding in the physician control device 2 and to retrieve theprescriptions using any suitable wired or wireless communicationschannel, including, but not limited to, a LAN, the Internet, a publictelephone switching network, Bluetooth, WLAN and the like.Alternatively, the prescriptions may be transferred to the vestibularstimulation devices 1 a, 1 b, 1 c, 1 d using one or more portable memorydevices, such as SD memory cards and/or USB memory sticks.

Each of the vestibular stimulation devices 1 a, 1 b, 1 c, 1 d may beconfigured to deliver one or more prescribed thermal waveforms to thevestibular system and/or the nervous system of the patient for whom theprescription was generated. For example, as described above, eachvestibular stimulation device 1 a, 1 b, 1 c, 1 d may be configured todeliver the prescribed thermal waveform(s) the vestibular system and/orthe nervous system of the patient by activating one or more TEDs to warmand/or cool an earpiece inserted into an ear canal of the patient.

Each of the vestibular stimulation devices 1 a, 1 b, 1 c, 1 d may beconfigured to generate feedback data. For example, the vestibularstimulation devices 1 a, 1 b, 1 c, 1 d may comprise one or more sensorsas described above, which may generate feedback data responsive todelivering the prescribed thermal waveform(s) to the vestibular systemand/or the nervous system of the patient. Similarly, the vestibularstimulation devices 1 a, 1 b, 1 c, 1 d may comprise a GUI configuredgenerate feedback data (e.g., patient feedback data) responsive to userinput.

Each of the vestibular stimulation devices 1 a, 1 b, 1 c, 1 d may beconfigured to store feedback data in a database residing therein (e.g.,a feedback database as described above) and/or to relay feedback data tothe physician control device 2. The vestibular stimulation devices 1 a,1 b, 1 c, 1 d may be configured to transmit feedback data to thephysician control device 2 over any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN; theInternet, a public telephone switching network, Bluetooth, WLAN and thelike. Likewise, the physician control device 2 may be configured toaccess one or more feedback databases residing in the vestibularstimulation devices 1 a, 1 b, 1 c, 1 d and to retrieve feedback datausing any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like. Alternatively, feedback data maybe transferred to the physician control device 2 using a portable memorydevice, such as an SD memory card or a USB memory stick.

The physician control device 2 may be configured to analyze feedbackdata received and/or retrieved from one or more of the vestibularstimulation devices 1 a, 1 b, 1 c, 1 d. For example, the physiciancontrol device 2 may be configured to use the feedback data to estimatethe thermal contact between one or more earpiece and the patient's earcanal(s), to calculate patient-specific time constants, to evaluate theprecision with the prescribed thermal waveform(s) was/were delivered,etc.

The physician control device 2 may be configured to modify one or morethermal waveforms responsive to analyzing feedback data received and/orretrieved from one or more of the vestibular stimulation devices 1 a, 1b, 1 c, 1 d. For example, the physician control device 2 may beconfigured to modify one or more parameters of a thermal waveformgenerated by the physician control device 2 and/or stored in a waveformdatabase residing therein. The physician control device 2 may beconfigured to modify the thermal waveform(s) automatically (e.g., thephysician control device 2 may be configured to automatically modify oneor more thermal waveforms if/when any of its analyses indicate that suchmodifications are likely to improve the efficacy of the thermalwaveform(s)) or responsive to user input.

The physician control device 2 may be configured to store one or moremodified thermal waveforms in a database residing therein (e.g., awaveform database as described above) and/or to relay the modifiedthermal waveform(s) to one or more of the vestibular stimulation devices1 a, 1 b, 1 c, 1 d. The physician control device 2 may be configured totransmit the modified thermal waveforms to the vestibular stimulationdevices 1 a, 1 b, 1 c, 1 d over any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN, theInternet, a public telephone switching network, Bluetooth, WLAN and thelike. Likewise, each of the vestibular stimulation devices 1 a, 1 b, 1c, 1 d may be configured to access a waveform database residing in thephysician control device 2 and to retrieve the modified thermalwaveform(s) using any suitable wired or wireless communications channel,including, but not limited to, a LAN, the Internet, a public telephoneswitching network, Bluetooth, WLAN and the like. Alternatively, themodified thermal waveform(s) may be transferred to one or more of thevestibular stimulation devices 1 a, 1 b, 1 c, 1 d using a portablememory device, such as an SD memory card or a USB memory stick.

The physician control device 2 may be configured to modify one or moreprescriptions responsive to analyzing feedback data received and/orretrieved from one or more of the vestibular stimulation devices 1 a, 1b, 1 c, 1 d. For example, the physician control device 2 may beconfigured to modify one or more parameters of a prescription generatedby the physician control device 2 and/or stored in a prescriptiondatabase residing therein. The physician control device 2 may beconfigured to modify the prescription(s) automatically (e.g., thephysician control device 2 may be configured to automatically modify oneor more prescriptions if/when any of its analyses indicate that suchmodifications are likely to improve the efficacy of the prescription(s))or responsive to user input.

The physician control device 2 may be configured to store one or moremodified prescriptions in a database residing therein (e.g., a waveformdatabase as described above) and/or to relay each of the modifiedprescription(s) to the vestibular stimulation device 1 a, 1 b, 1 c, 1 dassociated with the patient for whom the modified prescription(s)was/were generated. The physician control device 2 may be configured totransmit the modified prescription(s) to the vestibular stimulationdevices 1 a, 1 b, 1 c, 1 d over any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN, theInternet, a public telephone switching network, Bluetooth, WLAN and thelike. Likewise, each of the vestibular stimulation devices 1 a, 1 b, 1c, 1 d may be configured to access a prescription database residing inthe physician control device 2 and to retrieve the modifiedprescription(s) associated with the patient to whom the vestibularstimulation device 1 a, 1 b, 1 c, 1 d is associated using any suitablewired or wireless communications channel, including, but not limited to,a LAN, the Internet, a public telephone switching network, Bluetooth,WLAN and the like. Alternatively, the modified prescription(s) may betransferred to the vestibular stimulation devices 1 a, 1 b, 1 c, 1 dusing a portable memory device, such as an SD memory card or a USBmemory stick.

Each of the vestibular stimulation devices 1 a, 1 b, 1 c, 1 d may beconfigured to deliver one or more thermal waveforms to the vestibularsystem and/or the nervous system of the patient in accordance with oneor more modified prescriptions to the vestibular system and/or thenervous system of a patient. For example, as described above, thevestibular stimulation devices 1 a, 1 b, 1 c, 1 d may be configured todeliver the prescribed thermal waveform(s) the vestibular system and/orthe nervous system of the patient by activating one or more TEDs to warmand/or cool an earpiece inserted into an ear canal of the patient.

The physician control device 2 may be configured to generate one or moresoftware updates. Each software update may comprise, consist essentiallyof or consist of a set of instructions for modifying one or moreoperational parameters of the vestibular stimulation devices 1 a, 1 b, 1c, 1 d.

The physician control device 2 may be configured to store one or moresoftware updates in a database residing therein and/or to relay one ormore software updates to one or more of the vestibular stimulationdevices 1 a, 1 b, 1 c, 1 d. The physician control device 2 may beconfigured to transmit one or more software updates to the vestibularstimulation devices 1 a, 1 b, 1 c, 1 d over any suitable wired orwireless communications channel, including, but not limited to, a LAN,the Internet, a public telephone switching network, Bluetooth, WLAN andthe like. Likewise, each of the vestibular stimulation devices 1 a, 1 b,1 c, 1 d may be configured to access a database residing in thephysician control device 2 and to retrieve one or more software updatesusing any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like. Alternatively, one or moresoftware updates may be transferred to the vestibular stimulationdevices 1 a, 1 b, 1 c, 1 d using a portable memory device, such as an SDmemory card or a USB memory stick. The software update(s) may be relayedfrom the physician control device 2 to one or more of the vestibularstimulation devices 1 a, 1 b, 1 c, 1 d automatically (e.g., upongeneration, once per week, once per month, etc.) or in response to userinput.

Each of the vestibular stimulation devices 1 a, 1 b, 1 c, 1 d may beconfigured to modify one or more of its operational parametersresponsive to receiving and/or retrieving one or more software updatesfrom the physician control device 2. The vestibular stimulation devices1 a, 1 b, 1 c, 1 d may be configured to modify one or more of itsoperational parameters automatically ((e.g., upon receipt of thesoftware update(s), once per week, once per month, etc.) or in responseto user input.

As shown in FIG. 35, the vestibular stimulation system may comprise,consist essentially of or consist of a physician control device 2operatively connected to a vestibular stimulation device 1 comprising acontroller 11, a pair of earpieces 12 a, 12 b, a pair of TEDs 13 a, 13 band a pair of sensors 14 a, 14 b, wherein each of the TEDs 13 a, 13 b isoperatively connected to the controller 11 via a thermal stimulationlead 16 a, 16 b and thermally connected to one of the earpieces 12 a, 12b and wherein each of the sensors 14 a, 14 b is operatively connected tothe controller 11 via a wireless connection 17 a, 17 b and thermallyconnected to one of the earpieces 12 a, 12 b. In some such embodiments,the physician control device 2 comprises a waveform module 2 a, atreatment module 2 b, a network module 2 d, a feedback module 2 f, awaveform database 2 h, a prescription database 2 i and a feedbackdatabase 2 j, and the controller comprises a control module 11 c, anetwork module 11 d, a feedback module 11 f, a prescription database 11i and a feedback database 11 j.

The waveform module 2 a may be configured to generate one or morethermal waveforms (i.e., to generate the parameters, indications and/orapprovals of one or more thermal waveforms). The physician controldevice 2 may be configured such that the thermal waveforms generated bythe waveform module 2 a are transmitted directly to the treatment module2 b and/or are stored in the waveform database 2 h, from whence they maysubsequently be transmitted to and/or retrieved by the treatment module2 b.

The treatment module 2 b may be configured to retrieve the thermalwaveforms generated by the waveform module 2 a from the waveformdatabase 2 h.

The treatment module 2 b may be configured to generate a prescriptioncomprising a set of instructions for delivering one or more of thethermal waveforms generated by the waveform module 2 a to the vestibularsystem and/or the nervous system of a patient. The physician controldevice 2 may be configured such that the prescription generated by thetreatment module 2 b is transmitted directly to the vestibularstimulation device 1 by the network module 2 d residing in the physiciancontrol device 2 and/or is stored in the prescription database 2 iresiding in the physician control device 2, from whence it maysubsequently be transmitted to and/or retrieved by the vestibularstimulation device 1.

The network module 11 d residing in the controller 11 may be configuredto receive and/or retrieve the prescription from the physician controldevice 2 and to relay the prescription to the control module 11 c and/orto the prescription database 11 i residing in the controller 11.

The control module 11 c may be configured to retrieve the prescriptionfrom the prescription database 11 i residing in the controller 11.

The control module 11 c may be configured to deliver the prescribedthermal waveform(s) by activating the TEDs 13 a, 13 b in accordance withthe prescription (i.e., by activating the TEDs 13 a, 13 b to by warmand/or cool the earpieces 12 a, 12 b so as to deliver the prescribedthermal waveform(s)).

The feedback module 11 f residing in the controller 11 may be configuredto receive feedback data from the TEDs 13 a, 13 b and/or the sensors 14a, 14 b (e.g., data associated with the temperature of the earpieces 12a, 12 b, the temperature of the patient's ear canals, the impedancebetween the earpieces 12 a, 12 b, etc.). The controller 11 may beconfigured such that the feedback data received by the feedback module11 f is transmitted directly to the physician control device 2 by thenetwork module 11 d residing in the controller 11 and/or is stored inthe feedback database 11 j residing in the controller 11, from whence itmay subsequently be transmitted to and/or retrieved by the physiciancontrol device 2.

The network module 2 d residing in the physician control device 2 may beconfigured to receive and/or retrieve feedback data from the vestibularstimulation device 1 and to relay the feedback data to the feedbackmodule 2 f residing in the physician control device 2 and/or to thefeedback database 2 j residing in the physician control device 2, fromwhence it may subsequently be transmitted to and/or retrieved by thefeedback module 2 f.

The feedback module 2 f residing in the physician control device 2 maybe configured to retrieve feedback data from the feedback database 2 jresiding in the physician control device 2.

The feedback module 2 f residing in the physician control device 2 maybe configured to analyze the feedback data (e.g., to estimate thethermal contact between each of the earpieces 12 a, 12 b and thepatient's ear canals, to calculate patient-specific time constants, toevaluate the precision with the prescribed thermal waveform(s) wasdelivered, etc.). The physician control device 2 may be configured suchthat data associated with the feedback module's 2 f analysis aretransmitted directly to the waveform module 2 a and/or the treatmentmodule 2 b and/or are stored in the feedback database 2 j, from whencethey may subsequently be transmitted to and/or retrieved by the waveformmodule 2 a and/or the treatment module 2 b.

The waveform module 2 a may be configured to retrieve data associatedwith the feedback module's 2 f analysis from the feedback database 2 jresiding in the physician control device 2.

The waveform module 2 a may be configured to modify one or more of thethermal waveforms responsive to receiving and/or retrieving dataassociated with the feedback module's 2 f analysis. The waveform module2 a may be configured to modify the thermal waveform(s) automatically(e.g., the waveform module 2 a may be configured to periodically checkthe feedback database 2 j for new analyses and to automatically modifyone or more thermal waveforms if/when any analysis performed by thefeedback module 2 f indicates that such modifications are likely toimprove the efficacy of the thermal waveform(s)) or responsive to userinput. The physician control device 2 may be configured such that anymodifications made by the waveform module 2 a are relayed to thetreatment module 2 b as described above.

The treatment module 2 b may be configured to retrieve data associatedwith the feedback module's 2 f analysis from the feedback database 2 jresiding in the physician control device 2.

The treatment module 2 b may be configured to modify, update and/orextend the prescription responsive to receiving and/or retrieving dataassociated with the feedback module's 2 f analysis and/or to receivingand/or retrieving any modifications made by the waveform module 2 a. Thetreatment module 2 b may be configured to modify, update and/or extendthe prescription automatically (e.g., the treatment module 2 b may beconfigured to periodically check the waveform database 2 h for updatesand to automatically modify the prescription if/when one or more of theparameters, indications or approvals of a thermal waveform used in theprescription has been modified by the waveform module 2 a) or responsiveto user input. The physician control device 2 may be configured suchthat any modifications made by the treatment module 2 b are relayed tothe vestibular stimulation device 1 as described above.

As shown in FIG. 36, the vestibular stimulation system may comprise,consist essentially of or consist of a vestibular stimulation device 1operatively connected to a patient control device 3 that is operativelyconnected to a physician control device 2. In some embodiments, thevestibular stimulation device 1 is also operatively connected to thephysician control device 2 via an independent operative connection(i.e., independent of the patient control device 3).

The physician control device 2 may be configured to generate one or morethermal waveforms (i.e., to generate the parameters, indications and/orapprovals of one or more thermal waveforms) and/or to store the thermalwaveform(s) in a database (e.g., to store the parameters, indicationsand/or approvals of the thermal waveform(s) in a waveform database asdescribed above).

The physician control device 2 may be configured to generate one or moreprescriptions. Each prescription may comprise, consist essentially of orconsist of a set of instructions for delivering one or more thermalwaveforms to the vestibular system and/or the nervous system of apatient. In such embodiments, the prescription may comprise a set ofinstructions for delivering one or more of the thermal waveformsgenerated by the physician control device 2 to the vestibular systemand/or the nervous system of a patient.

The physician control device 2 may be configured to store one or moreprescriptions in a database residing therein (e.g., a prescriptiondatabase as described above) and/or relay one or more prescriptions tothe vestibular stimulation device 1 and/or the patient control device 3.The physician control device 2 may be configured to transmit one or moreprescriptions to the vestibular stimulation device 1 and/or the patientcontrol device 3 over any suitable wired or wireless communicationschannel, including, but not limited to, a LAN, the Internet, a publictelephone switching network, Bluetooth, WLAN and the like. Likewise, thevestibular stimulation device 1 and/or the patient control device 3 maybe configured to access a prescription database residing in thephysician control device 2 and to retrieve one or more prescriptionsusing any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like. Alternatively, one or moreprescriptions may be transferred to the vestibular stimulation device 1and/or the patient control device 3 using a portable memory device, suchas an SD memory card or a USB memory stick.

The patient control device 3 may be configured to store one or moreprescriptions in a database residing therein (e.g., a prescriptiondatabase as described above) and/or relay one or more prescriptions tothe vestibular stimulation device 1. The patient control device 3 may beconfigured to transmit one or more prescriptions to the vestibularstimulation device 1 over any suitable wired or wireless communicationschannel, including, but not limited to, a LAN, the Internet, a publictelephone switching network, Bluetooth, WLAN and the like. Likewise, thevestibular stimulation device 1 may be configured to access aprescription database residing in the patient control device 3 and toretrieve one or more prescriptions using any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN, theInternet, a public telephone switching network, Bluetooth, WLAN and thelike. Alternatively, one or more prescriptions may be transferred to thevestibular stimulation device 1 using a portable memory device, such asan SD memory card or a USB memory stick.

The vestibular stimulation device 1 may be configured to deliver one ormore prescribed thermal waveform(s) to the vestibular system and/or thenervous system of a patient. For example, as described above, thevestibular stimulation device 1 may be configured to deliver theprescribed thermal waveform(s) the vestibular system and/or the nervoussystem of the patient by activating one or more TEDs to warm and/or coolan earpiece inserted into an ear canal of the patient.

The vestibular stimulation device 1 may be configured to generatefeedback data. For example, the vestibular stimulation device 1 maycomprise one or more sensors as described above, which may generatefeedback data responsive to delivering the prescribed thermalwaveform(s) to the vestibular system and/or the nervous system of thepatient. Similarly, the vestibular stimulation device 1 may comprise aGUI configured generate feedback data (e.g., patient feedback data)responsive to user input.

The vestibular stimulation device 1 may be configured to store feedbackdata in a database residing therein (e.g., a feedback database asdescribed above) and/or to relay feedback data to the patient controldevice 3 and/or the physician control device 2. The vestibularstimulation device 1 may be configured to transmit feedback data to thepatient control device 3 and/or the physician control device 2 over anysuitable wired or wireless communications channel, including, but notlimited to, a LAN, the Internet, a public telephone switching network,Bluetooth, WLAN and the like. Likewise, the patient control device 3and/or the physician control device 2 may be configured to access afeedback database residing in the vestibular stimulation device 1 and toretrieve feedback data using any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN, theInternet, a public telephone switching network, Bluetooth, WLAN and thelike. Alternatively, feedback data may be transferred to the patientcontrol device 3 and/or the physician control device 2 using a portablememory device, such as an SD memory card or a USB memory stick.

The patient control device 3 may be configured to supplement feedbackdata received and/or retrieved from the vestibular stimulation device 1with additional feedback data (e.g., patient feedback data).

The patient control device 3 may be configured to store feedback data(including any additional feedback data generated by the patient controldevice 3) in a database residing therein (e.g., a feedback database asdescribed above) and/or to relay feedback data (including any additionalfeedback data generated by the patient control device 3) to thephysician control device 2. The patient control device 3 may beconfigured to transmit feedback data to the physician control device 2over any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like. Likewise, the physician controldevice 2 may be configured to access a feedback database residing in thepatient control device 3 and to retrieve feedback data using anysuitable wired or wireless communications channel, including, but notlimited to, a LAN, the Internet, a public telephone switching network,Bluetooth, WLAN and the like. Alternatively, feedback data may betransferred to the physician control device 2 using a portable memorydevice, such as an SD memory card or a USB memory stick.

The physician control device 2 may be configured to analyze feedbackdata received and/or retrieved from the vestibular stimulation device 1and/or the patient control device 3. For example, the physician controldevice 2 may be configured to use the feedback data to estimate thethermal contact between one or more earpiece and the patient's earcanal(s), to calculate patient-specific time constants, to evaluate theprecision with the prescribed thermal waveform(s) was/were delivered,etc.

The physician control device 2 may be configured to modify one or morethermal waveforms responsive to analyzing feedback data received and/orretrieved from the vestibular stimulation device 1 and/or the patientcontrol device 3. For example, the physician control device 2 may beconfigured to modify one or more parameters of a thermal waveformgenerated by the physician control device 2 and/or stored in a waveformdatabase residing therein. The physician control device 2 may beconfigured to modify the thermal waveform(s) automatically (e.g., thephysician control device 2 may be configured to automatically modify oneor more thermal waveforms if/when any of its analyses indicate that suchmodifications are likely to improve the efficacy of the thermalwaveform(s)) or responsive to user input.

The physician control device 2 may be configured to store one or moremodified thermal waveforms in a database residing therein (e.g., awaveform database as described above) and/or to relay the modifiedthermal waveform(s) to the vestibular stimulation device 1 and/or thepatient control device 3. The physician control device 2 may beconfigured to transmit the modified thermal waveform(s) to thevestibular stimulation device 1 and/or the patient control device 3 overany suitable wired or wireless communications channel, including, butnot limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like. Likewise, the vestibularstimulation device 1 and/or the patient control device 3 may beconfigured to access a waveform database residing in the physiciancontrol device 2 and to retrieve the modified thermal waveform(s) usingany suitable wired or wireless communications channel, including, butnot limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like. Alternatively, the modifiedthermal waveform(s) may be transferred to the vestibular stimulationdevice 1 and/or the patient control device 3 using a portable memorydevice, such as an SD memory card or a USB memory stick.

The physician control device 2 may be configured to modify one or moreprescriptions responsive to analyzing feedback data received and/orretrieved from the vestibular stimulation device 1 and/or the patientcontrol device 3. For example, the physician control device 2 may beconfigured to modify one or more parameters of a prescription generatedby the physician control device 2 and/or stored in a prescriptiondatabase residing therein. The physician control device 2 may beconfigured to modify the prescription(s) automatically (e.g., thephysician control device 2 may be configured to automatically modify oneor more prescriptions if/when any of its analyses indicate that suchmodifications are likely to improve the efficacy of the prescription(s))or responsive to user input.

The physician control device 2 may be configured to store one or moremodified prescriptions in a database residing therein (e.g., a waveformdatabase as described above) and/or to relay the modified thermalwaveform(s) to the vestibular stimulation device 1 and/or the patientcontrol device 3. The physician control device 2 may be configured totransmit the modified prescription(s) to the vestibular stimulationdevice 1 and/or the patient control device 3 over any suitable wired orwireless communications channel, including, but not limited to, a LAN,the Internet, a public telephone switching network, Bluetooth, WLAN andthe like. Likewise, the vestibular stimulation device 1 and/or thepatient control device 3 may be configured to access a prescriptiondatabase residing in the physician control device 2 and to retrieve themodified prescription(s) using any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN, theInternet, a public telephone switching network, Bluetooth, WLAN and thelike. Alternatively, the modified prescription(s) may be transferred tothe vestibular stimulation device 1 and/or the patient control device 3using a portable memory device, such as an SD memory card or a USBmemory stick.

The patient control device 3 may be configured to store one or moremodified prescriptions in a database residing therein (e.g., aprescription database as described above) and/or transmit one or moremodified prescriptions to the vestibular stimulation device 1. Thepatient control device 3 may be configured to transmit the modifiedprescription(s) to the vestibular stimulation device 1 over any suitablewired or wireless communications channel, including, but not limited to,a LAN, the Internet, a public telephone switching network, Bluetooth,WLAN and the like. Likewise, the vestibular stimulation device 1 may beconfigured to access a prescription database residing in the patientcontrol device 3 and to retrieve one or more modified prescriptionsusing any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like. Alternatively, one or moremodified prescriptions may be transferred to the vestibular stimulationdevice 1 using a portable memory device, such as an SD memory card or aUSB memory stick.

The vestibular stimulation device 1 may be configured to deliver one ormore thermal waveforms to the vestibular system and/or the nervoussystem of the patient in accordance with one or more modifiedprescriptions to the vestibular system and/or the nervous system of apatient. For example, as described above, the vestibular stimulationdevice 1 may be configured to deliver the prescribed thermal waveform(s)the vestibular system and/or the nervous system of the patient byactivating one or more TEDs to warm and/or cool an earpiece insertedinto an ear canal of the patient.

The physician control device 2 may be configured to generate one or moresoftware updates. Each software update may comprise, consist essentiallyof or consist of a set of instructions for modifying one or moreoperational parameters of the vestibular stimulation device 1 and/or thepatient control device 3.

The physician control device 2 may be configured to store one or moresoftware updates in a database residing therein and/or to relay one ormore software updates to the vestibular stimulation device 1 and/or thepatient control device 3. The physician control device 2 may beconfigured to transmit one or more software updates to the vestibularstimulation device 1 and/or the patient control device 3 over anysuitable wired or wireless communications channel, including, but notlimited to, a LAN, the Internet, a public telephone switching network,Bluetooth, WLAN and the like. Likewise, the vestibular stimulationdevice 1 and/or the patient control device 3 may be configured to accessa database residing in the physician control device 2 and to retrieveone or more software updates using any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN, theInternet, a public telephone switching network, Bluetooth, WLAN and thelike. Alternatively, one or more software updates may be transferred tothe vestibular stimulation device 1 and/or the patient control device 3using a portable memory device, such as an SD memory card or a USBmemory stick. The software update(s) may be relayed from the physiciancontrol device 2 to the vestibular stimulation device 1 and/or thepatient control device 3 automatically (e.g., upon generation, once perweek, once per month, etc.) or in response to user input.

The patient control device 3 may be configured to store one or moresoftware updates in a database residing therein and/or to relay one ormore software updates to the vestibular stimulation device 1. Thepatient control device 3 may be configured to transmit one or moresoftware updates to the vestibular stimulation device 1 over anysuitable wired or wireless communications channel, including, but notlimited to, a LAN, the Internet, a public telephone switching network,Bluetooth, WLAN and the like. Likewise, the vestibular stimulationdevice 1 may be configured to access a database residing in the patientcontrol device 3 and to retrieve one or more software updates using anysuitable wired or wireless communications channel, including, but notlimited to, a LAN, the Internet, a public telephone switching network,Bluetooth, WLAN and the like. Alternatively, one or more softwareupdates may be transferred to the vestibular stimulation device 1 usinga portable memory device, such as an SD memory card or a USB memorystick. The software update(s) may be relayed from the patient controldevice 3 to the vestibular stimulation device 1 automatically (e.g.,upon generation, once per week, once per month, etc.) or in response touser input.

The patient control device 3 may be configured to modify one or more ofits operational parameters responsive to receiving and/or retrieving oneor more software updates from the physician control device 2. Thepatient control device 3 may be configured to modify one or more of itsoperational parameters automatically ((e.g., upon receipt of thesoftware update(s), once per week, once per month, etc.) or in responseto user input.

The vestibular stimulation device 1 may be configured to modify one ormore of its operational parameters responsive to receiving and/orretrieving one or more software updates from the physician controldevice 2 and/or the patient control device 3. The vestibular stimulationdevice 1 may be configured to modify one or more of its operationalparameters automatically ((e.g., upon receipt of the software update(s),once per week, once per month, etc.) or in response to user input. Asshown in FIG. 37, the vestibular stimulation system may comprise,consist essentially of or consist of a physician control device 2operatively connected to a plurality of patient control devices 3 a, 3b, 3 c, 3 d, wherein each of said plurality of patient control devices 3a, 3 b, 3 c, 3 d is operatively connected to one of a plurality ofvestibular stimulation devices 1 a, 1 b, 1 c, 1 d. In some embodiments,one or more of the vestibular stimulation devices 1 a, 1 b, 1 c, 1 d isalso operatively connected to the physician control device 2 via anindependent operative connection (i.e., independent of the patientcontrol device 3 a, 3 b, 3 c, 3 d with which it is associated).

The physician control device 2 may be configured to generate one or morethermal waveforms (i.e., to generate the parameters, indications and/orapprovals of one or more thermal waveforms) and/or to store the thermalwaveform(s) in a database (e.g., to store the parameters, indicationsand/or approvals of the thermal waveform(s) in a waveform database asdescribed above).

The physician control device 2 may be configured to generate a pluralityof prescriptions, each comprising a set of instructions for deliveringone or more thermal waveforms to the vestibular system and/or thenervous system of a patient. In such embodiments, one or more of theprescriptions may comprise a set of instructions for delivering one ormore of the thermal waveforms generated by the physician control device2 to the vestibular system and/or the nervous system of a patient.

The physician control device 2 may be configured to store theprescriptions in a database residing therein (e.g., a prescriptiondatabase as described above) and/or to relay each prescription to avestibular stimulation device 1 a, 1 b, 1 c, 1 d and/or a patientcontrol device 3 a, 3 b, 3 c, 3 d associated with the patient for whomthe prescription was generated. The physician control device 2 may beconfigured to transmit the prescriptions to the vestibular stimulationdevices 1 a, 1 b, 1 c, 1 d and/or a patient control devices 3 a, 3 b, 3c, 3 d over any suitable wired or wireless communications channel,including, but not limited to, a LAN, the Internet, a public telephoneswitching network, Bluetooth, WLAN and the like. Likewise, each of thevestibular stimulation devices 1 a, 1 b, 1 c, 1 d and/or each of thepatient control devices 3 a, 3 b, 3 c, 3 d may be configured to access aprescription database residing in the physician control device 2 and toretrieve the prescriptions using any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN, theInternet, a public telephone switching network, Bluetooth, WLAN and thelike. Alternatively, the prescriptions may be transferred to thevestibular stimulation devices 1 a, 1 b, 1 c, 1 d and/or the patientcontrol devices 3 a, 3 b, 3 c, 3 d using one or more portable memorydevices, such as SD memory cards and/or USB memory sticks.

Each of the patient control devices 3 a, 3 b, 3 c, 3 d may be configuredto store one or more prescriptions in a database residing therein (e.g.,a prescription database as described above) and/or transmit one or moreprescriptions to the vestibular stimulation device 1 a, 1 b, 1 c, 1 dwith which it is associated. The patient control devices 3 a, 3 b, 3 c,3 d may be configured to transmit the prescription(s) to the vestibularstimulation device 1 a, 1 b, 1 c, 1 d with which it is associated overany suitable wired or wireless communications channel, including, butnot limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like. Likewise, each of the vestibularstimulation devices 1 a, 1 b, 1 c, 1 d may be configured to access aprescription database residing in the patient control device 3 a, 3 b, 3c, 3 d with which it is associated and to retrieve one or moreprescriptions using any suitable wired or wireless communicationschannel, including, but not limited to, a LAN, the Internet, a publictelephone switching network, Bluetooth, WLAN and the like.Alternatively, one or more prescriptions may be transferred to thevestibular stimulation devices 1 a, 1 b, 1 c, 1 d using a portablememory device, such as an SD memory card or a USB memory stick.

Each of the vestibular stimulation devices 1 a, 1 b, 1 c, 1 d may beconfigured to deliver one or more prescribed thermal waveforms to thevestibular system and/or the nervous system of the patient for whom theprescription was generated. For example, as described above, eachvestibular stimulation device 1 a, 1 b, 1 c, 1 d may be configured todeliver the prescribed thermal waveform(s) the vestibular system and/orthe nervous system of the patient by activating one or more TEDs to warmand/or cool an earpiece inserted into an ear canal of the patient.

Each of the vestibular stimulation devices 1 a, 1 b, 1 c, 1 d may beconfigured to generate feedback data. For example, the vestibularstimulation devices 1 a, 1 b, 1 c, 1 d may comprise one or more sensorsas described above, which may generate feedback data responsive todelivering the prescribed thermal waveform(s) to the vestibular systemand/or the nervous system of the patient. Similarly, the vestibularstimulation devices 1 a, 1 b, 1 c, 1 d may comprise a GUI configuredgenerate feedback data (e.g., patient feedback data) responsive to userinput.

Each of the vestibular stimulation devices 1 a, 1 b, 1 c, 1 d may beconfigured to store feedback data in a database residing therein (e.g.,a feedback database as described above) and/or to relay feedback data tothe patient control device 3 a, 3 b, 3 c, 3 d with which it isassociated and/or to the physician control device 2. The vestibularstimulation devices 1 a, 1 b, 1 c, 1 d may be configured to transmitfeedback data to the patient control device 3 a, 3 b, 3 c, 3 d withwhich it is associated and/or to the physician control device 2 over anysuitable wired or wireless communications channel, including, but notlimited to, a LAN, the Internet, a public telephone switching network,Bluetooth, WLAN and the like. Likewise, each of the patient controldevices 3 a, 3 b, 3 c, 3 d and/or to the physician control device 2 maybe configured to access one or more feedback databases residing in thevestibular stimulation devices 1 a, 1 b, 1 c, 1 d and to retrievefeedback data using any suitable wired or wireless communicationschannel, including, but not limited to, a LAN, the Internet, a publictelephone switching network, Bluetooth, WLAN and the like.Alternatively, feedback data may be transferred to the patient controldevices 3 a, 3 b, 3 c, 3 d and/or the physician control device 2 using aportable memory device, such as an SD memory card or a USB memory stick.

Each of the patient control devices 3 a, 3 b, 3 c, 3 d may be configuredto supplement feedback data received and/or retrieved from thevestibular stimulation device 1 a, 1 b, 1 c, 1 d with which it isassociated with additional feedback data (e.g., patient feedback data).

Each of the patient control devices 3 a, 3 b, 3 c, 3 d may be configuredto store feedback data (including any additional feedback data generatedby the patient control device 3) in a database residing therein (e.g., afeedback database as described above) and/or to relay feedback data(including any additional feedback data generated by the patient controldevice 3) to the physician control device 2. The patient control devices3 a, 3 b, 3 c, 3 d may be configured to transmit feedback data to thephysician control device 2 over any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN, theInternet, a public telephone switching network, Bluetooth, WLAN and thelike. Likewise, the physician control device 2 may be configured toaccess one or more feedback databases residing in the patient controldevices 3 a, 3 b, 3 c, 3 d and to retrieve feedback data using anysuitable wired or wireless communications channel, including, but notlimited to, a LAN, the Internet, a public telephone switching network,Bluetooth, WLAN and the like. Alternatively, feedback data may betransferred to the physician control device 2 using a portable memorydevice, such as an SD memory card or a USB memory stick.

The physician control device 2 may be configured to analyze feedbackdata received and/or retrieved from one or more of the vestibularstimulation devices 1 a, 1 b, 1 c, 1 d and/or one or more of the patientcontrol devices 3 a, 3 b, 3 c, 3 d. For example, the physician controldevice 2 may be configured to use the feedback data to estimate thethermal contact between one or more earpiece and the patient's earcanal(s), to calculate patient-specific time constants, to evaluate theprecision with the prescribed thermal waveform(s) was/were delivered,etc.

The physician control device 2 may be configured to modify one or morethermal waveforms responsive to analyzing feedback data received and/orretrieved from one or more of the vestibular stimulation devices 1 a, 1b, 1 c, 1 d and/or one or more of the patient control devices 3 a, 3 b,3 c, 3 d. For example, the physician control device 2 may be configuredto modify one or more parameters of a thermal waveform generated by thephysician control device 2 and/or stored in a waveform database residingtherein. The physician control device 2 may be configured to modify thethermal waveform(s) automatically (e.g., the physician control device 2may be configured to automatically modify one or more thermal waveformsif/when any of its analyses indicate that such modifications are likelyto improve the efficacy of the thermal waveform(s)) or responsive touser input.

The physician control device 2 may be configured to store one or moremodified thermal waveforms in a database residing therein (e.g., awaveform database as described above) and/or to relay the modifiedthermal waveform(s) to one or more of the vestibular stimulation devices1 a, 1 b, 1 c, 1 d and/or one or more of the patient control devices 3a, 3 b, 3 c, 3 d. The physician control device 2 may be configured totransmit the modified thermal waveform(s) to one or more of thevestibular stimulation devices 1 a, 1 b, 1 c, 1 d and/or one or more ofthe patient control devices 3 a, 3 b, 3 c, 3 d over any suitable wiredor wireless communications channel, including, but not limited to, aLAN, the Internet, a public telephone switching network, Bluetooth, WLANand the like. Likewise, one or more of the vestibular stimulationdevices 1 a, 1 b, 1 c, 1 d and/or one or more of the patient controldevices 3 a, 3 b, 3 c, 3 d may be configured to access a waveformdatabase residing in the physician control device 2 and to retrieve themodified thermal waveform(s) using any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN, theInternet, a public telephone switching network, Bluetooth, WLAN and thelike. Alternatively, the modified thermal waveform(s) may be transferredto one or more of the vestibular stimulation devices 1 a, 1 b, 1 c, 1 dand/or one or more of the patient control devices 3 a, 3 b, 3 c, 3 dusing a portable memory device, such as an SD memory card or a USBmemory stick.

The physician control device 2 may be configured to modify one or moreprescriptions responsive to analyzing feedback data received and/orretrieved from one or more of the vestibular stimulation devices 1 a, 1b, 1 c, 1 d and/or one or more of the patient control devices 3 a, 3 b,3 c, 3 d. For example, the physician control device 2 may be configuredto modify one or more parameters of a prescription generated by thephysician control device 2 and/or stored in a prescription databaseresiding therein. The physician control device 2 may be configured tomodify the prescription(s) automatically (e.g., the physician controldevice 2 may be configured to automatically modify one or moreprescriptions if/when any of its analyses indicate that suchmodifications are likely to improve the efficacy of the prescription(s))or responsive to user input.

The physician control device 2 may be configured to store one or moremodified prescriptions in a database residing therein (e.g., a waveformdatabase as described above) and/or to relay each of the modifiedprescription(s) to the vestibular stimulation devices 1 a, 1 b, 1 c, 1 dand/or one or more of the patient control devices 3 a, 3 b, 3 c, 3 dassociated with the patient for whom the prescription was generated. Thephysician control device 2 may be configured to transmit the modifiedprescription(s) to the vestibular stimulation devices 1 a, 1 b, 1 c, 1 dand/or the patient control devices 3 a, 3 b, 3 c, 3 d over any suitablewired or wireless communications channel, including, but not limited to,a LAN, the Internet, a public telephone switching network, Bluetooth,WLAN and the like. Likewise, each of the vestibular stimulation devices1 a, 1 b, 1 c, 1 d and/or each of the patient control devices 3 a, 3 b,3 c, 3 d may be configured to access a prescription database residing inthe physician control device 2 and to retrieve the modifiedprescription(s) associated with the patient to whom the vestibularstimulation device 1 a, 1 b, 1 c, 1 d and/or the patient control device3 a, 3 b, 3 c, 3 d is associated using any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN, theInternet, a public telephone switching network, Bluetooth, WLAN and thelike. Alternatively, the modified prescription(s) may be transferred tothe vestibular stimulation devices 1 a, 1 b, 1 c, 1 d and/or the patientcontrol devices 3 a, 3 b, 3 c, 3 d using a portable memory device, suchas an SD memory card or a USB memory stick.

Each of the patient control devices 3 a, 3 b, 3 c, 3 d may be configuredto store one or more modified prescriptions in a database residingtherein (e.g., a prescription database as described above) and/ortransmit one or more prescriptions to the vestibular stimulation device1 a, 1 b, 1 c, 1 d with which it is associated. The patient controldevices 3 a, 3 b, 3 c, 3 d may be configured to transmit the modifiedprescription(s) to the vestibular stimulation device 1 a, 1 b, 1 c, 1 dwith which it is associated over any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN, theInternet, a public telephone switching network, Bluetooth, WLAN and thelike. Likewise, each of the vestibular stimulation devices 1 a, 1 b, 1c, 1 d may be configured to access a prescription database residing inthe patient control device 3 a, 3 b, 3 c, 3 d with which it isassociated and to retrieve one or more modified prescriptions using anysuitable wired or wireless communications channel, including, but notlimited to, a LAN, the Internet, a public telephone switching network,Bluetooth, WLAN and the like. Alternatively, one or more modifiedprescriptions may be transferred to the vestibular stimulation devices 1a, 1 b, 1 c, 1 d using a portable memory device, such as an SD memorycard or a USB memory stick.

The vestibular stimulation devices 1 a, 1 b, 1 c, 1 d may be configuredto deliver one or more thermal waveforms to the vestibular system and/orthe nervous system of the patient in accordance with one or moremodified prescriptions to the vestibular system and/or the nervoussystem of a patient. For example, as described above, the vestibularstimulation devices 1 a, 1 b, 1 c, 1 d may be configured to deliver theprescribed thermal waveform(s) the vestibular system and/or the nervoussystem of the patient by activating one or more TEDs to warm and/or coolan earpiece inserted into an ear canal of the patient.

The physician control device 2 may be configured to generate one or moresoftware updates. Each software update may comprise, consist essentiallyof or consist of a set of instructions for modifying one or moreoperational parameters one or more of the vestibular stimulation devices1 a, 1 b, 1 c, 1 d and/or one or more of the patient control devices 3a, 3 b, 3 c, 3 d.

The physician control device 2 may be configured to store one or moresoftware updates in a database residing therein and/or to relay one ormore software updates to one or more of the vestibular stimulationdevices 1 a, 1 b, 1 c, 1 d and/or one or more of the patient controldevices 3 a, 3 b, 3 c, 3 d. The physician control device 2 may beconfigured to transmit one or more software updates to the vestibularstimulation devices 1 a, 1 b, 1 c, 1 d and/or the patient controldevices 3 a, 3 b, 3 c, 3 d over any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN, theInternet, a public telephone switching network, Bluetooth, WLAN and thelike. Likewise, each of the vestibular stimulation devices 1 a, 1 b, 1c, 1 d and/or each of the patient control devices 3 a, 3 b, 3 c, 3 d maybe configured to access a database residing in the physician controldevice 2 and to retrieve one or more software updates using any suitablewired or wireless communications channel, including, but not limited to,a LAN, the Internet, a public telephone switching network, Bluetooth,WLAN and the like. Alternatively, one or more software updates may betransferred to the vestibular stimulation devices 1 a, 1 b, 1 c, 1 dand/or the patient control devices 3 a, 3 b, 3 c, 3 d using a portablememory device, such as an SD memory card or a USB memory stick. Thesoftware update(s) may be relayed from the physician control device 2 tothe vestibular stimulation devices 1 a, 1 b, 1 c, 1 d and/or the patientcontrol devices 3 a, 3 b, 3 c, 3 d automatically (e.g., upon generation,once per week, once per month, etc.) or in response to user input.

Each of the patient control devices 3 a, 3 b, 3 c, 3 d may be configuredto store one or more software updates in a database residing thereinand/or transmit one or more software updates to the vestibularstimulation device 1 a, 1 b, 1 c, 1 d with which it is associated. Thepatient control devices 3 a, 3 b, 3 c, 3 d may be configured to transmitthe software update(s) to the vestibular stimulation device 1 a, 1 b, 1c, 1 d with which it is associated over any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN, theInternet, a public telephone switching network, Bluetooth, WLAN and thelike. Likewise, each of the vestibular stimulation devices 1 a, 1 b, 1c, 1 d may be configured to access a database residing in the patientcontrol device 3 a, 3 b, 3 c, 3 d with which it is associated and toretrieve one or more software updates using any suitable wired orwireless communications channel, including, but not limited to, a LAN,the Internet, a public telephone switching network, Bluetooth, WLAN andthe like. Alternatively, one or more software updates may be transferredto the vestibular stimulation devices 1 a, 1 b, 1 c, 1 d using aportable memory device, such as an SD memory card or a USB memory stick.

Each of the patient control devices 3 a, 3 b, 3 c, 3 d may be configuredto modify one or more of its operational parameters responsive toreceiving and/or retrieving one or more software updates from thephysician control device 2. The patient control devices 3 a, 3 b, 3 c, 3d may be configured to modify one or more of its operational parametersautomatically ((e.g., upon receipt of the software update(s), once perweek, once per month, etc.) or in response to user input.

Each of the vestibular stimulation devices 1 a, 1 b, 1 c, 1 d may beconfigured to modify one or more of its operational parametersresponsive to receiving and/or retrieving one or more software updatesfrom the physician control device 2 and/or the patient control device 3a, 3 b, 3 c, 3 d with which it is associated. The vestibular stimulationdevices 1 a, 1 b, 1 c, 1 d may be configured to modify one or more ofits operational parameters automatically ((e.g., upon receipt of thesoftware update(s), once per week, once per month, etc.) or in responseto user input.

As shown in FIG. 38, in some embodiments, the vestibular stimulationsystem comprises, consists essentially of or consists of a physiciancontrol device 2 operatively connected to a patient control device 3that is operatively connected to a vestibular stimulation device 1comprising a controller 11, an earpiece 12, a TED 13, a pair of sensors14 a, 14 b and a heat sink 15, wherein the TED 13 is operativelyconnected to the controller 11 via a thermal stimulation lead 16 andthermally connected between the earpiece 12 and the heat sink 15,wherein one of the sensors 14 a is operatively connected to thecontroller 11 via a wireless connection 17 a and thermally connected tothe heat sink 15 and wherein the other sensor 14 b is operativelyconnected to the controller 11 via a wireless connection 17 b andthermally connected to the earpiece 12. In some such embodiments, thephysician control device 2 comprises a waveform module 2 a, a treatmentmodule 2 b, a network module 2 d, a feedback module 2 f, a waveformdatabase 2 h, a prescription database 2 i and a feedback database 2 j,the patient control device 3 comprises a network module 3 d, a feedbackmodule 3 f, a prescription database 3 i and a feedback database 3 j andthe controller comprises a control module 11 c, a network module 11 dand a feedback module 11 f.

The waveform module 2 a may be configured to generate one or morethermal waveforms (i.e., to generate the parameters, indications and/orapprovals of one or more thermal waveforms). The physician controldevice may be configured such that the thermal waveforms generated bythe waveform module 2 a are transmitted directly to the treatment module2 b and/or are stored in the waveform database 2 h, from whence they maysubsequently be transmitted to and/or retrieved by the treatment module2 b.

The treatment module 2 b may be configured to retrieve the thermalwaveforms generated by the waveform module 2 a from the waveformdatabase 2 h.

The treatment module 2 b may be configured to generate a prescriptioncomprising a set of instructions for delivering one or more of thethermal waveforms generated by the waveform module 2 a to the vestibularsystem and/or the nervous system of a patient. The physician controldevice 2 may be configured such that the prescription generated by thetreatment module 2 b is transmitted directly to the patient controldevice 3 by the network module 2 d residing in the physician controldevice 2 and/or is stored in the prescription database 2 i residing inthe physician control device 2, from whence it may subsequently betransmitted to and/or retrieved by the patient control device 3.

The network module 11 d residing in the patient control device 3 may beconfigured to receive and/or retrieve the prescription from thephysician control device 2 and to relay the prescription to thevestibular stimulation device 1 and/or to the prescription database 11 iresiding in the patient control device 3.

The network module 11 d residing in the controller 11 may be configuredto receive and/or retrieve the prescription from the patient controldevice 3 and to relay the prescription to the control module 11.

The control module 11 c may be configured to deliver the prescribedthermal waveform(s) by activating the TED 13 in accordance with theprescription (i.e., by activating the TED 13 to by warm and/or cool theearpiece 12 so as to deliver the prescribed thermal waveform(s)).

The feedback module 11 f residing in the controller 11 may be configuredto receive feedback data from the TED 13 and/or the sensors 14 a, 14 b(e.g., data associated with the temperature of the earpiece 12, thetemperature of the patient's ear canals, the temperature of the heatsink 15, etc.). The controller 11 may be configured such that thefeedback data received by the feedback module 11 f is transmitteddirectly to the patient control device 3 by the network module 11 dresiding in the controller 11.

The network module 3 d residing in the patient control device 3 may beconfigured to receive feedback data from the vestibular stimulationdevice 1 and to relay the feedback data to the physician control device2 and/or to the feedback database 3 j residing in the patient controldevice 3, from whence it may subsequently be transmitted to and/orretrieved by the physician control device 2.

The patient control device 3 may be configured to supplement thefeedback data received from the vestibular stimulation device 1 withadditional feedback data (e.g., patient feedback data) and to relay theadditional feedback data to the physician control device 2 and/or to thefeedback database 3 j residing in the patient control device 3, fromwhence it may subsequently be transmitted to and/or retrieved by thephysician control device 2.

The network module 2 d residing in the physician control device 2 may beconfigured to receive and/or retrieve feedback data from the patientcontrol device 3 (including any additional feedback data supplied by thepatient control device 3) and to relay the feedback data to the feedbackmodule 2 f residing in the physician control device 2 and/or to thefeedback database 2 j residing in the physician control device 2, fromwhence it may subsequently be transmitted to and/or retrieved by thefeedback module 2 f residing in the physician control device 2.

The feedback module 2 f residing in the physician control device 2 maybe configured to retrieve the feedback data from the feedback database 2j residing in the physician control device 2.

The feedback module 2 f residing in the physician control device 2 maybe configured to analyze the feedback data (e.g., to estimate thethermal contact between each of the earpiece 12 a and the patient's earcanal, to calculate patient-specific time constants, to evaluate theprecision with the prescribed thermal waveform(s) was delivered, etc.).The physician control device 2 may be configured such that dataassociated with the feedback module's 2 f analysis are transmitteddirectly to the waveform module 2 a and/or the treatment module 2 band/or are stored in the feedback database 2 j, from whence they maysubsequently be transmitted to and/or retrieved by the waveform module 2a and/or the treatment module 2 b.

The waveform module 2 a may be configured to retrieve data associatedwith the feedback module's 2 f analysis from the feedback database 2 jresiding in the physician control device 2.

The waveform module 2 a may be configured to modify one or more of thethermal waveforms responsive to receiving and/or retrieving dataassociated with the feedback module's 2 f analysis. The physiciancontrol device 2 may be configured such that any modifications made bythe waveform module 2 a are relayed to the treatment module 2 b asdescribed above.

The treatment module 2 b may be configured to retrieve data associatedwith the feedback module's 2 f analysis from the feedback database 2 jresiding in the physician control device 2.

The treatment module 2 b may be configured to modify, update and/orextend the prescription responsive to receiving and/or retrieving dataassociated with the feedback module's 2 f analysis and/or to receivingand/or retrieving any modifications made by the waveform module 2 a. Thephysician control device 2 may be configured such that any modificationsmade by the treatment module 2 b are relayed to the vestibularstimulation device 1 and the patient control device 3 as describedabove.

As shown in FIG. 39 the vestibular stimulation system may comprise,consist essentially of or consist of a vestibular stimulation device 1operatively connected to a physician control device 2 that isoperatively connected to a physician support device 4.

The physician support device 4 may be configured to generate one or morethermal waveforms (i.e., to generate the parameters, indications and/orapprovals of one or more thermal waveforms) and/or to store the thermalwaveform(s) in a database (e.g., to store the parameters, indicationsand/or approvals of the thermal waveform(s) in a waveform database asdescribed above).

The physician support device 4 may be configured to store one or morethermal waveform(s) in a database residing therein (e.g., a waveformdatabase as described above) and/or relay one or more thermal waveformsto the physician control device 2. The physician support device 4 may beconfigured to transmit one or more prescriptions to the physiciancontrol device 2 over any suitable wired or wireless communicationschannel, including, but not limited to, a LAN, the Internet, a publictelephone switching network, Bluetooth, WLAN and the like. Likewise, thephysician control device 2 may be configured to access a waveformdatabase residing in the physician support device 4 and to retrieve oneor more thermal waveform(s) using any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN, theInternet, a public telephone switching network, Bluetooth, WLAN and thelike. Alternatively, one or more thermal waveform(s) may be transferredto the physician control device 2 using a portable memory device, suchas an SD memory card or a USB memory stick.

The physician control device 2 may be configured to generate one or moreprescriptions. Each prescription may comprise, consist essentially of orconsist of a set of instructions for delivering one or more thermalwaveforms to the vestibular system and/or the nervous system of apatient. In such embodiments, the prescription may comprise a set ofinstructions for delivering one or more of the thermal waveformsgenerated by the physician support device 4 to the vestibular systemand/or the nervous system of a patient.

The physician control device 2 may be configured to store one or moreprescriptions in a database residing therein (e.g., a prescriptiondatabase as described above) and/or to relay one or more prescriptionsto the vestibular stimulation device 1. The physician control device 2may be configured to transmit one or more prescriptions to thevestibular stimulation device 1 over any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN, theInternet, a public telephone switching network, Bluetooth, WLAN and thelike. Likewise, the vestibular stimulation device 1 may be configured toaccess a prescription database residing in the physician control device2 and to retrieve one or more prescriptions using any suitable wired orwireless communications channel, including, but not limited to, a LAN,the Internet, a public telephone switching network, Bluetooth, WLAN andthe like. Alternatively, one or more prescriptions may be transferred tothe vestibular stimulation device 1 using a portable memory device, suchas an SD memory card or a USB memory stick.

The vestibular stimulation device 1 may be configured to deliver one ormore prescribed thermal waveforms to the vestibular system and/or thenervous system of a patient. For example, as described above, thevestibular stimulation device 1 may be configured to deliver theprescribed thermal waveform(s) the vestibular system and/or the nervoussystem of the patient by activating one or more TEDs to warm and/or coolan earpiece inserted into an ear canal of the patient.

The vestibular stimulation device 1 may be configured to generatefeedback data. For example, the vestibular stimulation device 1 maycomprise one or more sensors as described above, which may generatefeedback data responsive to delivering the prescribed thermalwaveform(s) to the vestibular system and/or the nervous system of thepatient. Similarly, the vestibular stimulation device 1 may comprise aGUI configured generate feedback data (e.g., patient feedback data)responsive to user input.

The vestibular stimulation device 1 may be configured to store feedbackdata in a database residing therein (e.g., a feedback database asdescribed above) and/or to relay feedback data to the physician controldevice 2 and/or the physician support device 4. The vestibularstimulation device 1 may be configured to transmit feedback data to thephysician control device 2 and/or the physician support device 4 overany suitable wired or wireless communications channel, including, butnot limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like. Likewise, the physician controldevice 2 and/or the physician support device 4 may be configured toaccess a feedback database residing in the vestibular stimulation device1 and to retrieve feedback data using any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN, theInternet, a public telephone switching network, Bluetooth, WLAN and thelike. Alternatively, feedback data may be transferred to the physiciancontrol device 2 and/or the physician support device 4 using a portablememory device, such as an SD memory card or a USB memory stick.

The physician control device 2 may be configured to supplement feedbackdata received and/or retrieved from the vestibular stimulation device 1with additional feedback data (e.g., physician feedback data).

The physician control device 2 may be configured to store feedback data(including any additional feedback data supplied by the physiciancontrol device 2) in a database residing therein (e.g., a feedbackdatabase as described above) and/or to relay feedback data (includingany additional feedback data supplied by the physician control device 2)to the physician support device 4. The physician control device 2 may beconfigured to transmit feedback data to the physician support device 4over any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like. Likewise, the physician supportdevice 4 may be configured to access a feedback database residing in thephysician control device 2 and to retrieve feedback data using anysuitable wired or wireless communications channel, including, but notlimited to, a LAN, the Internet, a public telephone switching network,Bluetooth, WLAN and the like. Alternatively, feedback data may betransferred to the physician support device 4 using a portable memorydevice, such as an SD memory card or a USB memory stick.

The physician control device 2 may be configured to analyze feedbackdata received and/or retrieved from the vestibular stimulation device 1.For example, the physician control device 2 may be configured to use thefeedback data to estimate the thermal contact between one or moreearpiece and the patient's ear canal(s), to calculate patient-specifictime constants, to evaluate the precision with the prescribed thermalwaveform(s) was/were delivered, etc.

The physician support device 4 may be configured to analyze feedbackdata received and/or retrieved from the vestibular stimulation device 1and/or the physician control device 2. For example, the physiciansupport device 4 may be configured to use the feedback data to identifywaveform characteristics that may be linked to increased/decreasedefficacy with regard to the treatment of a givendisease/disorder/injury, to identify modifications that are likely toincrease the effectiveness of a given thermal waveform, class of thermalwaveforms or combination of thermal waveforms; to identify newdiseases/disorders/injuries for which a given thermal waveform, class ofthermal waveforms, combination of thermal waveforms and/or treatmentregimen may provide an effective treatment; to predict which thermalwaveform(s) or combination(s) of thermal waveforms may be most effectivein treating a given disease/disorder/injury; to identify thermalwaveforms, classes of thermal waveforms and/or combinations of thermalwaveforms that are not likely to be effective in the treatment of agiven disease/disorder/injury, etc. In some embodiments, the feedbackmodule is configured to identify new idealized thermal waveforms byidentifying one or more diseases/disorders/injuries for which a thermalwaveform or class of waveforms is likely to be an effective treatment(e.g., by identifying a new thermal waveform that belongs to a class ofwaveforms known to be effective in treating one or morediseases/disorders/injuries), to identify one or more additionaldiseases/disorders/injuries for which a previously identified idealizedthermal waveform is likely to be an effective treatment (e.g., byidentifying, in a population of patients receiving treatment with anidealized thermal waveform for treatment of a firstdisease/disorder/injury, one or more co-morbiddiseases/disorders/injuries that also appear to be effectively treatedby the idealized thermal waveform) and/or to identify one or morediseases/disorders/injuries for which a previously identified idealizedthermal waveform is not likely to be an effective treatment (e.g., oneor more of the diseases/disorders/injuries for which an idealizedthermal waveform had previously been indicated and/or approved may beremoved from the list of indications for that thermal waveform or forthe class of thermal waveforms to which it belongs).

The physician support device 4 may be configured to modify one or morethermal waveforms responsive to analyzing feedback data received and/orretrieved from the vestibular stimulation device 1 and/or the physiciancontrol device 2. For example, the physician support device 4 may beconfigured to modify one or more parameters of a thermal waveformgenerated by the physician support device 4 and/or stored in a waveformdatabase residing therein. The physician support device 4 may beconfigured to modify the thermal waveform(s) automatically (e.g., thephysician support device 4 may be configured to automatically modify oneor more thermal waveforms if/when any of its analyses indicate that suchmodifications are likely to improve the efficacy of the thermalwaveform(s)) or responsive to user input.

The physician support device 4 may be configured to store one or moremodified thermal waveforms in a database residing therein (e.g., awaveform database as described above) and/or to relay the modifiedthermal waveform(s) to the physician control device 2. The physiciansupport device 4 may be configured to transmit one or more modifiedthermal waveforms to the physician control device 2 over any suitablewired or wireless communications channel, including, but not limited to,a LAN, the Internet, a public telephone switching network, Bluetooth,WLAN and the like. Likewise, the physician control device 2 may beconfigured to access a waveform database residing in the physiciansupport device 4 and to retrieve the modified thermal waveform(s) usingany suitable wired or wireless communications channel, including, butnot limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like. Alternatively, the modifiedthermal waveform(s) may be transferred to the physician control device 2using a portable memory device, such as an SD memory card or a USBmemory stick.

The physician control device 2 may be configured to modify one or moreprescriptions responsive to analyzing feedback data received and/orretrieved from the vestibular stimulation device 1 and/or to receivingand/or retrieving one or more modified thermal waveforms from thephysician support device 4. For example, the physician control device 2may be configured to modify one or more parameters of a prescriptiongenerated by the physician control device 2 and/or stored in aprescription database residing therein. The physician control device 2may be configured to modify the prescription(s) automatically (e.g., thephysician control device 2 may be configured to automatically modify oneor more prescriptions if/when any of its analyses indicate that suchmodifications are likely to improve the efficacy of the prescription(s))or responsive to user input.

The physician control device 2 may be configured to store one or moremodified prescriptions in a database residing therein (e.g., a waveformdatabase as described above) and/or to relay the modified thermalwaveform(s) to the vestibular stimulation device 1. The physiciancontrol device 2 may be configured to transmit one or more modifiedprescriptions to the vestibular stimulation device 1 over any suitablewired or wireless communications channel, including, but not limited to,a LAN, the Internet, a public telephone switching network, Bluetooth,WLAN and the like. Likewise, the vestibular stimulation device 1 may beconfigured to access a prescription database residing in the physiciancontrol device 2 and to retrieve the modified prescription(s) using anysuitable wired or wireless communications channel, including, but notlimited to, a LAN, the Internet, a public telephone switching network,Bluetooth, WLAN and the like. Alternatively, the modifiedprescription(s) may be transferred to the vestibular stimulation device1 using a portable memory device, such as an SD memory card or a USBmemory stick.

The vestibular stimulation device 1 may be configured to deliver one ormore thermal waveforms to the vestibular system and/or the nervoussystem of the patient in accordance with one or more modifiedprescriptions to the vestibular system and/or the nervous system of apatient. For example, as described above, the vestibular stimulationdevice 1 may be configured to deliver the prescribed thermal waveform(s)the vestibular system and/or the nervous system of the patient byactivating one or more TEDs to warm and/or cool an earpiece insertedinto an ear canal of the patient.

The physician support device 4 may be configured to generate one or moresoftware updates. Each software update may comprise, consist essentiallyof or consist of a set of instructions for modifying one or moreoperational parameters of the vestibular stimulation device 1 and/or thephysician control device 2.

The physician support device 4 may be configured to store one or moresoftware updates in a database residing therein and/or to relay one ormore software updates to the vestibular stimulation device 1 and/or thephysician control device 2. The physician support device 4 may beconfigured to transmit one or more software updates to the vestibularstimulation device 1 and/or the physician control device 2 over anysuitable wired or wireless communications channel, including, but notlimited to, a LAN, the Internet, a public telephone switching network,Bluetooth, WLAN and the like. Likewise, the vestibular stimulationdevice 1 and/or the physician control device 2 may be configured toaccess a database residing in the physician support device 4 and toretrieve one or more software updates using any suitable wired orwireless communications channel, including, but not limited to, a LAN,the Internet, a public telephone switching network, Bluetooth, WLAN andthe like. Alternatively, one or more software updates may be transferredto the vestibular stimulation device 1 and/or the physician controldevice 2 using a portable memory device, such as an SD memory card or aUSB memory stick. The software update(s) may be relayed from thephysician support device 4 to the vestibular stimulation device 1 and/orthe physician control device 2 automatically (e.g., upon generation,once per week, once per month, etc.) or in response to user input.

The physician control device 2 may be configured to store one or moresoftware updates in a database residing therein and/or to relay one ormore software updates to the vestibular stimulation device 1. Thephysician control device 2 may be configured to transmit one or moresoftware updates to the vestibular stimulation device 1 over anysuitable wired or wireless communications channel, including, but notlimited to, a LAN, the Internet, a public telephone switching network,Bluetooth, WLAN and the like. Likewise, the vestibular stimulationdevice 1 may be configured to access a database residing in thephysician control device 2 and to retrieve one or more software updatesusing any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like. Alternatively, one or moresoftware updates may be transferred to the vestibular stimulation device1 using a portable memory device, such as an SD memory card or a USBmemory stick. The software update(s) may be relayed from the physiciancontrol device 2 to the vestibular stimulation device 1 automatically(e.g., upon generation, once per week, once per month, etc.) or inresponse to user input.

The physician control device 2 may be configured to modify one or moreof its operational parameters responsive to receiving and/or retrievingone or more software updates from the physician support device 4. Thephysician control device 2 may be configured to modify one or more ofits operational parameters automatically ((e.g., upon receipt of thesoftware update(s), once per week, once per month, etc.) or in responseto user input.

The vestibular stimulation device 1 may be configured to modify one ormore of its operational parameters responsive to receiving and/orretrieving one or more software updates from the physician supportdevice 4 and/or the physician control device 2. The vestibularstimulation device 1 may be configured to modify one or more of itsoperational parameters automatically ((e.g., upon receipt of thesoftware update(s), once per week, once per month, etc.) or in responseto user input.

As shown in FIG. 40; in some embodiments, the vestibular stimulationsystem comprises, consists essentially of or consists of a physiciansupport device 4 operatively connected to a plurality of physiciancontrol devices 2 a, 2 b wherein each of said plurality of physiciancontrol devices 2 a, 2 b is operatively connected a plurality ofvestibular stimulation devices 1 a, 1 b, 1 c, 1 d. In some embodiments,one or more of the vestibular stimulation devices 1 a, 1 b, 1 c, 1 d isalso operatively connected to the physician supprt device 4 via anindependent operative connection (i.e., independent of the physiciancontrol device 2 a, 2 b with which it is associated).

The physician support device 4 may be configured to generate one or morethermal waveforms (i.e., to generate the parameters, indications and/orapprovals of one or more thermal waveforms) and/or to store the thermalwaveform(s) in a database (e.g., to store the parameters, indicationsand/or approvals of the thermal waveform(s) in a waveform database asdescribed above).

The physician support device 4 may be configured to store one or morethermal waveform(s) in a database residing therein (e.g., a waveformdatabase as described above) and/or relay one or more thermal waveformsto one or more of the physician control devices 2 a, 2 b. The physiciansupport device 4 may be configured to transmit one or more prescriptionsto the physician control devices 2 a, 2 b over any suitable wired orwireless communications channel, including, but not limited to, a LAN,the Internet, a public telephone switching network, Bluetooth, WLAN andthe like. Likewise, each of the physician control devices 2 a, 2 b maybe configured to access a waveform database residing in the physiciansupport device 4 and to retrieve one or more thermal waveform(s) usingany suitable wired or wireless communications channel, including, butnot limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like. Alternatively, one or morethermal waveform(s) may be transferred to the physician control devices2 a, 2 b using a portable memory device, such as an SD memory card or aUSB memory stick.

Each of the physician control devices 2 a, 2 b may be configured togenerate a plurality of prescriptions, each comprising a set ofinstructions for delivering one or more thermal waveforms to thevestibular system and/or the nervous system of a patient. In suchembodiments, one or more of the prescriptions may comprise a set ofinstructions for delivering one or more of the thermal waveformsgenerated by the physician support device 4 to the vestibular systemand/or the nervous system of a patient.

Each of the physician control devices 2 a, 2 b may be configured tostore one or more prescriptions in a database residing therein (e.g., aprescription database as described above) and/or to relay eachprescription to a vestibular stimulation device 1 a, 1 b, 1 c, 1 dassociated with the patient for whom the prescription was generated. Thephysician control devices 2 a, 2 b may be configured to transmit theprescriptions to the vestibular stimulation devices 1 a, 1 b, 1 c, 1 dover any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like. Likewise, each of the vestibularstimulation devices 1 a, 1 b, 1 c, 1 d may be configured to access aprescription database residing in the physician control device 2 a, 2 bwith which it is associated and to retrieve the prescriptions using anysuitable wired or wireless communications channel, including, but notlimited to, a LAN, the Internet, a public telephone switching network,Bluetooth, WLAN and the like. Alternatively, the prescriptions may betransferred to the vestibular stimulation devices 1 a, 1 b, 1 c, 1 dusing one or more portable memory devices, such as SD memory cardsand/or USB memory sticks.

Each of the vestibular stimulation devices 1 a, 1 b, 1 c, 1 d may beconfigured to deliver one or more prescribed thermal waveforms to thevestibular system and/or the nervous system of the patient for whom theprescription was generated. For example, as described above, eachvestibular stimulation device 1 a, 1 b, 1 c, 1 d may be configured todeliver the prescribed thermal waveform(s) the vestibular system and/orthe nervous system of the patient by activating one or more TEDs to warmand/or cool an earpiece inserted into an ear canal of the patient.

Each of the vestibular stimulation devices 1 a, 1 b, 1 c, 1 d may beconfigured to store feedback data in a database residing therein (e.g.,a feedback database as described above) and/or to relay feedback data tothe physician control device 2 a, 2 b with which it is associated and/orto the physician support device 4. Each of the vestibular stimulationdevices 1 a, 1 b, 1 c, 1 d may be configured to transmit feedback datato the physician control device 2 a, 2 b with which it is associatedand/or to the physician support device 4 over any suitable wired orwireless communications channel, including, but not limited to, a LAN,the Internet, a public telephone switching network, Bluetooth, WLAN andthe like. Likewise, each of the physician control devices 2 a, 2 band/or to the physician support device 4 may be configured to access oneor more feedback databases residing in the vestibular stimulationdevices 1 a, 1 b, 1 c, 1 d and to retrieve feedback data using anysuitable wired or wireless communications channel, including, but notlimited to, a LAN, the Internet, a public telephone switching network,Bluetooth, WLAN and the like. Alternatively, feedback data may betransferred to the physician control devices 2 a, 2 b and/or to thephysician support device 4 using a portable memory device, such as an SDmemory card or a USB memory stick.

Each of the physician control devices 2 a, 2 b may be configured tosupplement feedback data received and/or retrieved from the vestibularstimulation device 1 a, 1 b, 1 c, 1 d with which it is associated withadditional feedback data (e.g., physician feedback data).

Each of the physician control devices 2 a, 2 b may be configured tostore feedback data (including any additional feedback data supplied bythe physician control devices 2 a, 2 b) in a database residing therein(e.g., a feedback database as described above) and/or to relay feedbackdata (including any additional feedback data supplied by the physiciancontrol devices 2 a, 2 b) to the physician support device 4. Thephysician control devices 2 a, 2 b 2 may be configured to transmitfeedback data to the physician support device 4 over any suitable wiredor wireless communications channel, including, but not limited to, aLAN, the Internet, a public telephone switching network, Bluetooth, WLANand the like. Likewise, the physician support device 4 may be configuredto access one or more feedback databases residing in the physiciancontrol devices 2 a, 2 b and to retrieve feedback data using anysuitable wired or wireless communications channel, including, but notlimited to, a LAN, the Internet, a public telephone switching network,Bluetooth, WLAN and the like. Alternatively, feedback data may betransferred to the physician support device 4 using a portable memorydevice, such as an SD memory card or a USB memory stick.

Each of the physician control devices 2 a, 2 b may be configured toanalyze feedback data received and/or retrieved from the vestibularstimulation device 1 a, 1 b, 1 c, 1 d with which it is associated. Forexample, the physician control devices 2 a, 2 b may be configured to usethe feedback data to estimate the thermal contact between one or moreearpiece and the patient's ear canal(s), to calculate patient-specifictime constants, to evaluate the precision with the prescribed thermalwaveform(s) was/were delivered, etc.

The physician support device 4 may be configured to analyze feedbackdata received and/or retrieved from the vestibular stimulation devices 1a, 1 b, 1 c, 1 d and/or the physician control devices 2 a, 2 b. Forexample, the physician support device 4 may be configured to use thefeedback data to identify waveform characteristics that may be linked toincreased/decreased efficacy with regard to the treatment of a givendisease/disorder/injury, to identify modifications that are likely toincrease the effectiveness of a given thermal waveform, class of thermalwaveforms or combination of thermal waveforms; to identify newdiseases/disorders/injuries for which a given thermal waveform, class ofthermal waveforms, combination of thermal waveforms and/or treatmentregimen may provide an effective treatment; to predict which thermalwaveform(s) or combination(s) of thermal waveforms may be most effectivein treating a given disease/disorder/injury; to identify thermalwaveforms, classes of thermal waveforms and/or combinations of thermalwaveforms that are not likely to be effective in the treatment of agiven disease/disorder/injury, etc. In some embodiments, the feedbackmodule is configured to identify new idealized thermal waveforms byidentifying one or more diseases/disorders/injuries for which a thermalwaveform or class of waveforms is likely to be an effective treatment(e.g., by identifying a new thermal waveform that belongs to a class ofwaveforms known to be effective in treating one or morediseases/disorders/injuries), to identify one or more additionaldiseases/disorders/injuries for which a previously identified idealizedthermal waveform is likely to be an effective treatment (e.g., byidentifying, in a population of patients receiving treatment with anidealized thermal waveform for treatment of a firstdisease/disorder/injury, one or more co-morbiddiseases/disorders/injuries that also appear to be effectively treatedby the idealized thermal waveform) and/or to identify one or morediseases/disorders/injuries for which a previously identified idealizedthermal waveform is not likely to be an effective treatment (e.g., oneor more of the diseases/disorders/injuries for which an idealizedthermal waveform had previously been indicated and/or approved may beremoved from the list of indications for that thermal waveform or forthe class of thermal waveforms to which it belongs).

The physician support device 4 may be configured to modify one or morethermal waveforms responsive to analyzing feedback data received and/orretrieved from the vestibular stimulation devices 1 a, 1 b, 1 c, 1 dand/or the physician control devices 2 a, 2 b. For example, thephysician support device 4 may be configured to modify one or moreparameters of a thermal waveform generated by the physician supportdevice 4 and/or stored in a waveform database residing therein. Thephysician support device 4 may be configured to modify the thermalwaveform(s) automatically (e.g., the physician support device 4 may beconfigured to automatically modify one or more thermal waveforms if/whenany of its analyses indicate that such modifications are likely toimprove the efficacy of the thermal waveform(s)) or responsive to userinput.

The physician support device 4 may be configured to store one or moremodified thermal waveforms in a database residing therein (e.g., awaveform database as described above) and/or to relay the modifiedthermal waveform(s) to one or more of the physician control devices 2 a,2 b. The physician support device 4 may be configured to transmit one ormore modified thermal waveforms to one or more of the physician controldevices 2 a, 2 b over any suitable wired or wireless communicationschannel, including, but not limited to, a LAN, the Internet, a publictelephone switching network, Bluetooth, WLAN and the like. Likewise,each of the physician control devices 2 a, 2 b may be configured toaccess a waveform database residing in the physician support device 4and to retrieve the modified thermal waveform(s) using any suitablewired or wireless communications channel, including, but not limited to,a LAN, the Internet, a public telephone switching network, Bluetooth,WLAN and the like. Alternatively, the modified thermal waveform(s) maybe transferred to the physician control devices 2 a, 2 b using aportable memory device, such as an SD memory card or a USB memory stick.

Each of the physician control devices 2 a, 2 b may be configured tomodify one or more prescriptions responsive to analyzing feedback datareceived and/or retrieved from the vestibular stimulation device 1 a, 1b, 1 c, 1 d with which it is associated and/or to receiving and/orretrieving one or more modified thermal waveforms from the physiciansupport device 4. For example, the physician control devices 2 a, 2 bmay be configured to modify one or more parameters of a prescriptiongenerated by the physician control devices 2 a, 2 b and/or stored in aprescription database residing therein. The physician control devices 2a, 2 b may be configured to modify the prescription(s) automatically(e.g., the physician control devices 2 a, 2 b may be configured toautomatically modify one or more prescriptions if/when any of itsanalyses indicate that such modifications are likely to improve theefficacy of the prescription(s)) or responsive to user input.

Each of the physician control devices 2 a, 2 b may be configured tostore one or more modified prescriptions in a database residing therein(e.g., a waveform database as described above) and/or to relay themodified thermal waveform(s) to the vestibular stimulation device 1 a, 1b, 1 c, 1 d with which it is associated. The physician control devices 2a, 2 b may be configured to transmit one or more modified prescriptionsto the vestibular stimulation device 1 a, 1 b, 1 c, 1 d with which it isassociated over any suitable wired or wireless communications channel,including, but not limited to, a LAN, the Internet, a public telephoneswitching network, Bluetooth, WLAN and the like. Likewise, each of thevestibular stimulation devices 1 a, 1 b, 1 c, 1 d may be configured toaccess a prescription database residing in the physician control device2 a, 2 b with which it is associated and to retrieve the modifiedprescription(s) using any suitable wired or wireless communicationschannel, including, but not limited to, a LAN, the Internet, a publictelephone switching network, Bluetooth, WLAN and the like.Alternatively, the modified prescription(s) may be transferred to thevestibular stimulation devices 1 a, 1 b, 1 c, 1 d using a portablememory device, such as an SD memory card or a USB memory stick.

Each of the vestibular stimulation devices 1 a, 1 b, 1 c, 1 d may beconfigured to deliver one or more thermal waveforms to the vestibularsystem and/or the nervous system of the patient in accordance with oneor more modified prescriptions to the vestibular system and/or thenervous system of a patient. For example, as described above, thevestibular stimulation device 1 may be configured to deliver theprescribed thermal waveform(s) the vestibular system and/or the nervoussystem of the patient by activating one or more TEDs to warm and/or coolan earpiece inserted into an ear canal of the patient.

The physician support device 4 may be configured to generate one or moresoftware updates. Each software update may comprise, consist essentiallyof or consist of a set of instructions for modifying one or moreoperational parameters one or more of the vestibular stimulation devices1 a, 1 b, 1 c, 1 d and/or one or more of the physician control devices 2a, 2 b.

The physician support device 4 may be configured to store one or moresoftware updates in a database residing therein and/or to relay one ormore software updates to one or more of the vestibular stimulationdevices 1 a, 1 b, 1 c, 1 d and/or one or more of the physician controldevices 2 a, 2 b. The physician support device 4 may be configured totransmit one or more software updates to the vestibular stimulationdevices 1 a, 1 b, 1 c, 1 d and/or the physician control devices 2 a, 2 bover any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like. Likewise, each of the vestibularstimulation devices 1 a, 1 b, 1 c, 1 d and/or each of the physiciancontrol devices 2 a, 2 b may be configured to access a database residingin the physician support device 4 and to retrieve one or more softwareupdates using any suitable wired or wireless communications channel,including, but not limited to, a LAN, the Internet, a public telephoneswitching network, Bluetooth, WLAN and the like. Alternatively, one ormore software updates may be transferred to the vestibular stimulationdevices 1 a, 1 b, 1 c, 1 d and/or the physician control devices 2 a, 2 busing a portable memory device, such as an SD memory card or a USBmemory stick. The software update(s) may be relayed from the physiciansupport device 4 to the vestibular stimulation devices 1 a, 1 b, 1 c, 1d and/or the physician control devices 2 a, 2 b automatically (e.g.,upon generation, once per week, once per month, etc.) or in response touser input.

Each of the physician control devices 2 a, 2 b may be configured tostore one or more software updates in a database residing therein and/ortransmit one or more software updates to one or more of the vestibularstimulation devices 1 a, 1 b, 1 c, 1 d with which it is associated. Thephysician control devices 2 a, 2 b may be configured to transmit thesoftware update(s) to one or more of the vestibular stimulation devices1 a, 1 b, 1 c, 1 d with which it is associated over any suitable wiredor wireless communications channel, including, but not limited to, aLAN, the Internet, a public telephone switching network, Bluetooth, WLANand the like. Likewise, each of the vestibular stimulation devices 1 a,1 b, 1 c, 1 d may be configured to access a database residing in thephysician control device 2 a, 2 b with which it is associated and toretrieve one or more software updates using any suitable wired orwireless communications channel, including, but not limited to, a LAN,the Internet, a public telephone switching network, Bluetooth, WLAN andthe like. Alternatively, one or more software updates may be transferredto the vestibular stimulation devices 1 a, 1 b, 1 c, 1 d using aportable memory device, such as an SD memory card or a USB memory stick.

Each of the physician control devices 2 a, 2 b may be configured tomodify one or more of its operational parameters responsive to receivingand/or retrieving one or more software updates from the physiciansupport device 4. The physician control devices 2 a, 2 b may beconfigured to modify one or more of its operational parametersautomatically ((e.g., upon receipt of the software update(s), once perweek, once per month, etc.) or in response to user input.

Each of the vestibular stimulation devices 1 a, 1 b, 1 c, 1 d may beconfigured to modify one or more of its operational parametersresponsive to receiving and/or retrieving one or more software updatesfrom the physician support device 4 and/or the physician control device2 a, 2 b with which it is associated. The vestibular stimulation devices1 a, 1 b, 1 c, 1 d may be configured to modify one or more of itsoperational parameters automatically ((e.g., upon receipt of thesoftware update(s), once per week, once per month, etc.) or in responseto user input.

As shown in FIG. 41, in some embodiments, the vestibular stimulationsystem comprises, consists essentially of or consists of a physiciansupport device 4, a physician control device 2 and a vestibularstimulation device 1 comprising a controller 11, a pair of earpieces 12a, 12 b, a pair of TEDs 13 a, 13 b and a pair of sensors 14 a, 14 b,wherein each of the TEDs 13 a, 13 b is operatively connected to thecontroller 11 via a thermal stimulation lead 16 a, 16 b and thermallyconnected to one of the earpieces 12 a, 12 b and wherein each of thesensors 14 a, 14 b is operatively connected to the controller 11 via awireless connection 17 a, 17 b and thermally connected to one of theearpieces 12 a, 12 b. In some such embodiments, the physician supportdevice 4 comprises a waveform module 4 a, a network module 4 d, afeedback module 4 f, a waveform database 4 h, a feedback database 4 jand a patient history database 4 k; the physician control device 2comprises a treatment module 2 b, a network module 2 d, a feedbackmodule 2 f, a waveform database 2 h, a prescription database 2 i, afeedback database 2 j and a patient history database 2 k and thecontroller comprises a control module 11 c, a network module 11 d, afeedback module 11 f, a prescription database 11 i and a feedbackdatabase 11 j.

The waveform module 4 a may be configured to generate one or morethermal waveforms (i.e., to generate the parameters, indications and/orapprovals of one or more thermal waveforms). The physician supportdevice 4 may be configured such that the thermal waveforms generated bythe waveform module 4 a are transmitted directly to the physiciancontrol device 2 by the network module residing in the physician supportdevice 4 and/or are stored in the waveform database 4 h residing in thephysician support device 4, from whence they may subsequently betransmitted to and/or retrieved by the physician control device 2.

The network module 2 d residing in the physician control device 2 may beconfigured to receive and/or retrieve thermal waveforms generated by thewaveform module 4 a from the physician support device 4 and to relay thethermal waveforms to the treatment module 2 b and/or to the waveformdatabase 2 h residing in the physician control device 2, from whencethey may subsequently be transmitted to and/or retrieved by thetreatment module 2 b.

The treatment module 2 b may be configured to retrieve the thermalwaveforms generated by the waveform module 4 a from the waveformdatabase 2 h residing in the physician control device 2 and/or from thewaveform database 4 h residing in the physician support device 4.

The treatment module 2 b may be configured to generate a prescriptioncomprising a set of instructions for delivering one or more of thethermal waveforms generated by the waveform module 4 a to the vestibularsystem and/or the nervous system of a patient. The physician controldevice 2 may be configured such that the prescription generated by thetreatment module 2 b is transmitted directly to the vestibularstimulation device 1 by the network module 2 d residing in the physiciancontrol device 2 and/or is stored in the prescription database 2 iresiding in the physician control device 2, from whence it maysubsequently be transmitted to and/or retrieved by the vestibularstimulation device 1.

The network module 11 d residing in the controller 11 may be configuredto receive and/or retrieve the prescription from the physician controldevice 2 and to relay the prescription to the control module 11 e and/orto the prescription database 11 i residing in the controller 11.

The control module 11 e may be configured to retrieve the prescriptionfrom the prescription database 11 i residing in the controller 11.

The control module 11 e may be configured to deliver the prescribedthermal waveform(s) by activating the TEDs 13 a, 13 b in accordance withthe prescription (i.e., by activating the TEDs 13 a, 13 b to by warmand/or cool the earpieces 12 a, 12 b so as to deliver the prescribedthermal waveform(s)).

The feedback module 11 f residing in the controller 11 may be configuredto receive feedback data from the TEDs 13 a, 13 b and/or the sensors 14a, 14 b (e.g., data associated with the temperature of the earpieces 12a, 12 b, the temperature of the patient's ear canals, the impedancebetween the earpieces 12 a, 12 b, etc.). The controller 11 may beconfigured such that the feedback data received by the feedback module11 f is transmitted directly to the physician control device 2 and/orthe physician support device 4 by the network module 11 d residing inthe controller 11 and/or is stored in the feedback database 11 jresiding in the controller 11, from whence it may subsequently betransmitted to and/or retrieved by the physician control device 2 and/orthe physician support device 4.

The network module 2 d residing in the physician control device 2 may beconfigured to receive and/or retrieve feedback data from the vestibularstimulation device 1 and to relay the feedback data to the physiciansupport device 4, to the feedback module 2 f residing in the physiciancontrol device 2 and/or to the feedback database 2 j residing in thephysician control device 2, from whence they may subsequently betransmitted to and/or retrieved by the physician support device 4 and/orthe feedback module 2 f residing in the physician control device 2.

The physician control device 2 may be configured to supplement thefeedback data received and/or retrieved from the vestibular stimulationdevice 1 with additional feedback data (e.g., physician commentsregarding the effectiveness of a given thermal waveform, class ofthermal waveforms, combination of thermal waveforms, etc.) and to relaythe additional feedback data to the physician support device 4, to thefeedback module 2 f residing in the physician control device 2 and/or tothe feedback database 2 j residing in the physician control device 2,from whence they may subsequently be transmitted to and/or retrieved bythe physician support device 4 and/or the feedback module 2 f residingin the physician control device 2.

The feedback module 2 f residing in the physician control device 2 maybe configured to retrieve feedback data (including any additionalfeedback data supplied by the physician control device 2) from thefeedback database 2 j residing in the physician control device 2.

The feedback module 2 f residing in the physician control device 2 maybe configured to analyze the feedback data (e.g., to estimate thethermal contact between each of the earpieces 12 a, 12 b and thepatient's ear canals, to calculate patient-specific time constants, toevaluate the precision with the prescribed thermal waveform(s) wasdelivered, etc.). The physician control device 2 may be configured suchthat data associated with the feedback module's 2 f analysis aretransmitted to the physician support device 4 and/or to the feedbackdatabase 2 j residing in the physician control device 2, from whencethey may subsequently be transmitted to and/or retrieved by thephysician support device 4.

The network module 4 d residing in the physician support device 4 may beconfigured to receive and/or retrieve feedback data (including anyadditional feedback data supplied by the physician control device 2and/or data associated with any analysis performed by the feedbackmodule 2 f residing in the physician control device 2) from thephysician control device 2 and to relay the feedback data to thefeedback module 4 f residing in the physician support device 4 and/or tothe feedback database 4 j residing in the physician support device 4,from whence they may subsequently be transmitted to and/or retrieved bythe feedback module 4 f residing in the physician support device 4.

The physician control device 2 may be configured to generate and/ormodify patient information (e.g., information related to a patient'sidentity, medical history, current symptoms, current prescriptions,etc.). The physician control device 2 may be configured to transmitpatient information to the physician control device 4 and/or to thepatient history database 2 k residing in the physician control device 2,from whence it may subsequently be transmitted to and/or retrieved bythe physician support device 4.

The network module 4 d residing in the physician support device 4 may beconfigured to receive and/or retrieve patient information from thephysician control device 2 and to relay the patient information to thefeedback module 4 f residing in the physician support device 4 and/or tothe patient history database 4 k residing in the physician supportdevice 4, from whence it may subsequently be transmitted to and/orretrieved by the feedback module 4 f residing in the physician supportdevice 4.

The feedback module 4 f residing in the physician support device 4 maybe configured to analyze the feedback data and/or the patientinformation (e.g., to identify modifications that are likely to increasethe effectiveness of a given thermal waveform, class of thermalwaveforms or combination of thermal waveforms). The physician supportdevice 4 may be configured such that data associated with the feedbackmodule's 4 f analysis are transmitted to the physician control device 2,to the waveform module 4 a and/or to the feedback database 4 j residingin the physician support device 4, from whence they may subsequently betransmitted to and/or retrieved by the physician control device 2 and/orthe waveform module 4 a.

The network module 2 d residing in the physician control device 2 may beconfigured to receive and/or retrieve data associated with the feedbackmodule's 4 f analysis from the physician support device 4 and to relaythat data to the treatment module 2 b and/or to the feedback database 2j residing in the physician control device 2, from whence they maysubsequently be transmitted to and/or retrieved by the treatment module2 b.

The waveform module 4 a may be configured to retrieve data associatedwith the feedback module's 4 f analysis from the feedback database 4 jresiding in the physician support device 4.

The waveform module 4 a may be configured to modify one or more of thethermal waveforms responsive to receiving and/or retrieving dataassociated with the feedback module's 4 f analysis (e.g., by modifyingone or more of the parameters, indications and/or approvals of a thermalwaveform). The waveform module 4 a may be configured to modify thethermal waveform(s) automatically (e.g., the waveform module 4 a may beconfigured to periodically check the feedback database 4 j for newanalyses and to automatically modify one or more thermal waveformsif/when any analysis performed by the feedback module 4 f indicates thatsuch modifications are likely to improve the efficacy of the thermalwaveform(s)) or responsive to user input. The physician support device 4may be configured such that any modifications made by the waveformmodule 4 a are relayed to the physician control device 2 as describedabove.

The treatment module 2 b may be configured to retrieve data associatedwith the feedback module's 2 f analysis from the feedback database 2 jresiding in the physician control device 2 and/or to retrieve anymodifications made by the waveform module 4 a from the waveform database2 h residing in the physician control device 2 and/or from the waveformdatabase residing in the physician support device 4.

The treatment module 2 b may be configured to modify, update and/orextend the prescription responsive to receiving and/or retrieving dataassociated with the feedback module's 2 f analysis and/or to receivingand/or retrieving any modifications made by the waveform module 2 a. Thetreatment module 2 b may be configured to modify, update and/or extendthe prescription automatically (e.g., the treatment module 2 b may beconfigured to periodically check the waveform database 2 h for updatesand to automatically modify the prescription if/when one or more of theparameters, indications or approvals of a thermal waveform used in theprescription has been modified by the waveform module 4 a) or responsiveto user input. The physician control device 2 may be configured suchthat any modifications made by the treatment module 2 b are relayed tothe vestibular stimulation device 1 as described above.

As shown in FIG. 42 the vestibular stimulation system may comprise,consist essentially of or consist of a vestibular stimulation device 1operatively connected to a physician control device 2 that isoperatively connected to a physician support device 4, which is itselfoperatively connected to a registry 5.

The registry 5 may be configured to store data associated with one ormore thermal waveforms (e.g., one or more idealized thermal waveforms)in a database residing therein (e.g., to store the parameters,indications and/or approvals of the thermal waveform(s) in a waveformdatabase as described above) and/or to relay data associated with one ormore thermal waveforms to the physician support device 4. The registry 5may be configured to transmit one or more thermal waveforms to thephysician support device 4 over any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN, theInternet, a public telephone switching network, Bluetooth, WLAN and thelike. Likewise, the physician support device 4 may be configured toaccess a waveform database residing in the registry 5 and to retrieveone or more thermal waveform(s) using any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN, theInternet, a public telephone switching network, Bluetooth, WLAN and thelike. Alternatively, one or more thermal waveform(s) may be transferredto the physician support device 4 using a portable memory device, suchas an SD memory card or a USB memory stick.

The physician support device 4 may be configured to modify one or moreof the thermal waveforms received/retrieved from the registry 5 (i.e.,to modify one or more of the parameters, indications and/or approvals ofone or more thermal waveforms) and/or to store the modified thermalwaveform(s) in a database (e.g., to store the parameters, indicationsand/or approvals of the modified thermal waveform(s) in a waveformdatabase as described above).

The physician support device 4 may be configured to store one or morethermal waveform(s) (including the modified thermal waveforms discussedabove) in a database residing therein (e.g., a waveform database asdescribed above) and/or relay one or more thermal waveforms to thephysician control device 2. The physician support device 4 may beconfigured to transmit one or more prescriptions to the physiciancontrol device 2 over any suitable wired or wireless communicationschannel, including, but not limited to, a LAN, the Internet, a publictelephone switching network, Bluetooth, WLAN and the like. Likewise, thephysician control device 2 may be configured to access a waveformdatabase residing in the physician support device 4 and to retrieve oneor more thermal waveform(s) using any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN, theInternet, a public telephone switching network, Bluetooth, WLAN and thelike. Alternatively, one or more thermal waveform(s) may be transferredto the physician control device 2 using a portable memory device, suchas an SD memory card or a USB memory stick.

The physician control device 2 may be configured to generate one or moreprescriptions. Each prescription may comprise, consist essentially of orconsist of a set of instructions for delivering one or more thermalwaveforms to the vestibular system and/or the nervous system of apatient. In such embodiments, the prescription may comprise a set ofinstructions for delivering one or more of the thermal waveformsgenerated by the physician support device 4 to the vestibular systemand/or the nervous system of a patient.

The physician control device 2 may be configured to store one or moreprescriptions in a database residing therein (e.g., a prescriptiondatabase as described above) and/or to relay one or more prescriptionsto the vestibular stimulation device 1. The physician control device 2may be configured to transmit one or more prescriptions to thevestibular stimulation device 1 over any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN, theInternet, a public telephone switching network, Bluetooth, WLAN and thelike. Likewise, the vestibular stimulation device 1 may be configured toaccess a prescription database residing in the physician control device2 and to retrieve one or more prescriptions using any suitable wired orwireless communications channel, including, but not limited to, a LAN,the Internet, a public telephone switching network, Bluetooth, WLAN andthe like. Alternatively, one or more prescriptions may be transferred tothe vestibular stimulation device 1 using a portable memory device, suchas an SD memory card or a USB memory stick.

The vestibular stimulation device 1 may be configured to deliver one ormore prescribed thermal waveforms to the vestibular system and/or thenervous system of a patient. For example, as described above, thevestibular stimulation device 1 may be configured to deliver theprescribed thermal waveform(s) the vestibular system and/or the nervoussystem of the patient by activating one or more TEDs to warm and/or coolan earpiece inserted into an ear canal of the patient.

The vestibular stimulation device 1 may be configured to generatefeedback data. For example, the vestibular stimulation device 1 maycomprise one or more sensors as described above, which may generatefeedback data responsive to delivering the prescribed thermalwaveform(s) to the vestibular system and/or the nervous system of thepatient. Similarly, the vestibular stimulation device 1 may comprise aGUI configured generate feedback data (e.g., patient feedback data)responsive to user input.

The vestibular stimulation device 1 may be configured to store feedbackdata in a database residing therein (e.g., a feedback database asdescribed above) and/or to relay feedback data to the physician controldevice 2, the physician support device 4 and/or the registry 5. Thevestibular stimulation device 1 may be configured to transmit feedbackdata to the physician control device 2, the physician support device 4and/or the registry 5 over any suitable wired or wireless communicationschannel, including, but not limited to, a LAN, the Internet, a publictelephone switching network, Bluetooth, WLAN and the like. Likewise, thephysician control device 2, the physician support device 4 and/or theregistry 5 may be configured to access a feedback database residing inthe vestibular stimulation device 1 and to retrieve feedback data usingany suitable wired or wireless communications channel, including, butnot limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like. Alternatively, feedback data maybe transferred to the physician control device 2, the physician supportdevice 4 and/or the registry 5 using a portable memory device, such asan SD memory card or a USB memory stick.

The physician control device 2 may be configured to supplement feedbackdata received and/or retrieved from the vestibular stimulation device 1with additional feedback data (e.g., physician feedback data).

The physician control device 2 may be configured to analyze feedbackdata received and/or retrieved from the vestibular stimulation device 1.For example, the physician control device 2 may be configured to use thefeedback data to estimate the thermal contact between one or moreearpiece and the patient's ear canal(s), to calculate patient-specifictime constants, to evaluate the precision with the prescribed thermalwaveform(s) was/were delivered, etc.

The physician control device 2 may be configured to store feedback data(including any additional feedback data supplied by the physiciancontrol device 2 and any data associated with the analysis describedabove) in a database residing therein (e.g., a feedback database asdescribed above) and/or to relay feedback data (including any additionalfeedback data supplied by the physician control device 2 and any dataassociated with the analysis described above) to the physician supportdevice 4 and/or the registry 5. The physician control device 2 may beconfigured to transmit feedback data to the physician support device 4and/or the registry 5 over any suitable wired or wireless communicationschannel, including, but not limited to, a LAN, the Internet, a publictelephone switching network, Bluetooth, WLAN and the like. Likewise, thephysician support device 4 and/or the registry 5 may be configured toaccess a feedback database residing in the physician control device 2and to retrieve feedback data using any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN, theInternet, a public telephone switching network, Bluetooth, WLAN and thelike. Alternatively, feedback data may be transferred to the physiciansupport device 4 and/or the registry 5 using a portable memory device,such as an SD memory card or a USB memory stick.

The physician support device 4 may be configured to supplement feedbackdata received and/or retrieved from the vestibular stimulation device 1and/or the physician control device 2 with additional feedback data(e.g., physician feedback data).

The physician support device 4 may be configured to analyze feedbackdata received and/or retrieved from the vestibular stimulation device 1and/or the physician control device 2. For example, the physiciansupport device 4 may be configured to use the feedback data to identifywaveform characteristics that may be linked to increased/decreasedefficacy with regard to the treatment of a givendisease/disorder/injury, to identify modifications that are likely toincrease the effectiveness of a given thermal waveform, class of thermalwaveforms or combination of thermal waveforms; to identify newdiseases/disorders/injuries for which a given thermal waveform, class ofthermal waveforms, combination of thermal waveforms and/or treatmentregimen may provide an effective treatment; to predict which thermalwaveform(s) or combination(s) of thermal waveforms may be most effectivein treating a given disease/disorder/injury; to identify thermalwaveforms, classes of thermal waveforms and/or combinations of thermalwaveforms that are not likely to be effective in the treatment of agiven disease/disorder/injury, etc. In some embodiments, the feedbackmodule is configured to identify new idealized thermal waveforms byidentifying one or more diseases/disorders/injuries for which a thermalwaveform or class of waveforms is likely to be an effective treatment(e.g., by identifying a new thermal waveform that belongs to a class ofwaveforms known to be effective in treating one or morediseases/disorders/injuries), to identify one or more additionaldiseases/disorders/injuries for which a previously identified idealizedthermal waveform is likely to be an effective treatment (e.g., byidentifying, in a population of patients receiving treatment with anidealized thermal waveform for treatment of a firstdisease/disorder/injury, one or more co-morbiddiseases/disorders/injuries that also appear to be effectively treatedby the idealized thermal waveform) and/or to identify one or morediseases/disorders/injuries for which a previously identified idealizedthermal waveform is not likely to be an effective treatment (e.g., oneor more of the diseases/disorders/injuries for which an idealizedthermal waveform had previously been indicated and/or approved may beremoved from the list of indications for that thermal waveform or forthe class of thermal waveforms to which it belongs).

The physician support device 4 may be configured to store feedback data(including any additional feedback data supplied by the physiciansupport device 4 and any data associated with the analysis describedabove) in a database residing therein (e.g., a feedback database asdescribed above) and/or to relay feedback data (including any additionalfeedback data supplied by the physician support device 4 and any dataassociated with the analysis described above) to the registry 5. Thephysician support device 4 may be configured to transmit feedback datato the registry 5 over any suitable wired or wireless communicationschannel, including, but not limited to, a LAN, the Internet, a publictelephone switching network, Bluetooth, WLAN and the like. Likewise, theregistry 5 may be configured to access a feedback database residing inthe physician support device 4 and to retrieve feedback data using anysuitable wired or wireless communications channel, including, but notlimited to, a LAN, the Internet, a public telephone switching network,Bluetooth, WLAN and the like. Alternatively, feedback data may betransferred to the registry 5 using a portable memory device, such as anSD memory card or a USB memory stick.

The physician support device 4 may be configured to modify one or morethermal waveforms responsive to analyzing feedback data received and/orretrieved from the vestibular stimulation device 1 and/or the physiciancontrol device 2. For example, the physician support device 4 may beconfigured to modify one or more parameters of the thermal waveform(s)received/retrieved from the registry 5. The physician support device 4may be configured to modify the thermal waveform(s) automatically (e.g.,the physician support device 4 may be configured to automatically modifyone or more thermal waveforms if/when any of its analyses indicate thatsuch modifications are likely to improve the efficacy of the thermalwaveform(s)) or responsive to user input.

The physician support device 4 may be configured to store one or moremodified thermal waveforms in a database residing therein (e.g., awaveform database as described above) and/or to relay the modifiedthermal waveform(s) to the physician control device 2 and/or theregistry 5. The physician support device 4 may be configured to transmitone or more modified thermal waveforms to the physician control device 2and/or the registry 5 over any suitable wired or wireless communicationschannel, including, but not limited to, a LAN, the Internet, a publictelephone switching network, Bluetooth, WLAN and the like. Likewise, thephysician control device 2 and/or the registry 5 may be configured toaccess a waveform database residing in the physician support device 4and to retrieve the modified thermal waveform(s) using any suitablewired or wireless communications channel, including, but not limited to,a LAN, the Internet, a public telephone switching network, Bluetooth,WLAN and the like. Alternatively, the modified thermal waveform(s) maybe transferred to the physician control device 2 and/or the registry 5using a portable memory device, such as an SD memory card or a USBmemory stick.

The physician control device 2 may be configured to modify one or moreprescriptions responsive to analyzing feedback data received and/orretrieved from the vestibular stimulation device 1 and/or to receivingand/or retrieving one or more modified thermal waveforms from thephysician support device 4. For example, the physician control device 2may be configured to modify one or more parameters of a prescriptiongenerated by the physician control device 2 and/or stored in aprescription database residing therein. The physician control device 2may be configured to modify the prescription(s) automatically (e.g., thephysician control device 2 may be configured to automatically modify oneor more prescriptions if/when any of its analyses indicate that suchmodifications are likely to improve the efficacy of the prescription(s))or responsive to user input.

The physician control device 2 may be configured to store one or moremodified prescriptions in a database residing therein (e.g., a waveformdatabase as described above) and/or to relay the modified thermalwaveform(s) to the vestibular stimulation device 1. The physiciancontrol device 2 may be configured to transmit one or more modifiedprescriptions to the vestibular stimulation device 1 over any suitablewired or wireless communications channel, including, but not limited to,a LAN, the Internet, a public telephone switching network, Bluetooth,WLAN and the like. Likewise, the vestibular stimulation device 1 may beconfigured to access a prescription database residing in the physiciancontrol device 2 and to retrieve the modified prescription(s) using anysuitable wired or wireless communications channel, including, but notlimited to, a LAN, the Internet, a public telephone switching network,Bluetooth, WLAN and the like. Alternatively, the modifiedprescription(s) may be transferred to the vestibular stimulation device1 using a portable memory device, such as an SD memory card or a USBmemory stick.

The vestibular stimulation device 1 may be configured to deliver one ormore thermal waveforms to the vestibular system and/or the nervoussystem of the patient in accordance with one or more modifiedprescriptions to the vestibular system and/or the nervous system of apatient. For example, as described above, the vestibular stimulationdevice 1 may be configured to deliver the prescribed thermal waveform(s)the vestibular system and/or the nervous system of the patient byactivating one or more TEDs to warm and/or cool an earpiece insertedinto an ear canal of the patient.

The registry 5 may be configured to generate one or more softwareupdates. Each software update may comprise, consist essentially of orconsist of a set of instructions for modifying one or more operationalparameters of the vestibular stimulation device 1, the physician controldevice 2 and/or the physician support device 4.

The registry 5 may be configured to store one or more software updatesin a database residing therein and/or to relay one or more softwareupdates to the vestibular stimulation device 1, the physician controldevice 2 and/or the physician support device 4. The registry 5 may beconfigured to transmit one or more software updates the vestibularstimulation device 1, the physician control device 2 and/or thephysician support device 4 over any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN, theInternet, a public telephone switching network, Bluetooth, WLAN and thelike. Likewise, the vestibular stimulation device 1, the physiciancontrol device 2 and/or the physician support device 4 may be configuredto access a database residing in the registry 5 and to retrieve one ormore software updates using any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN, theInternet, a public telephone switching network, Bluetooth, WLAN and thelike. Alternatively, one or more software updates may be transferred tothe vestibular stimulation device 1, the physician control device 2and/or the physician support device 4 using a portable memory device,such as an SD memory card or a USB memory stick. The software update(s)may be relayed from the registry 5 to the vestibular stimulation device1, the physician control device 2 and/or the physician support device 4automatically (e.g., upon generation, once per week, once per month,etc.) or in response to user input.

The physician support device 4 may be configured to store one or moresoftware updates in a database residing therein and/or to relay one ormore software updates to the vestibular stimulation device 1 and/or thephysician control device 2. The physician support device 4 may beconfigured to transmit one or more software updates to the vestibularstimulation device 1 and/or the physician control device 2 over anysuitable wired or wireless communications channel, including, but notlimited to, a LAN, the Internet, a public telephone switching network,Bluetooth, WLAN and the like. Likewise, the vestibular stimulationdevice 1 and/or the physician control device 2 may be configured toaccess a database residing in the physician support device 4 and toretrieve one or more software updates using any suitable wired orwireless communications channel, including, but not limited to, a LAN,the Internet, a public telephone switching network, Bluetooth, WLAN andthe like. Alternatively, one or more software updates may be transferredto the vestibular stimulation device 1 and/or the physician controldevice 2 using a portable memory device, such as an SD memory card or aUSB memory stick. The software update(s) may be relayed from thephysician support device 4 to the vestibular stimulation device 1 and/orthe physician control device 2 automatically (e.g., upon generation,once per week, once per month, etc.) or in response to user input.

The physician control device 2 may be configured to store one or moresoftware updates in a database residing therein and/or to relay one ormore software updates to the vestibular stimulation device 1. Thephysician control device 2 may be configured to transmit one or moresoftware updates to the vestibular stimulation device 1 over anysuitable wired or wireless communications channel, including, but notlimited to, a LAN, the Internet, a public telephone switching network,Bluetooth, WLAN and the like. Likewise, the vestibular stimulationdevice 1 may be configured to access a database residing in thephysician control device 2 and to retrieve one or more software updatesusing any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like. Alternatively, one or moresoftware updates may be transferred to the vestibular stimulation device1 using a portable memory device, such as an SD memory card or a USBmemory stick. The software update(s) may be relayed from the physiciancontrol device 2 to the vestibular stimulation device 1 automatically(e.g., upon generation, once per week, once per month, etc.) or inresponse to user input.

The physician control device 2 may be configured to modify one or moreof its operational parameters responsive to receiving and/or retrievingone or more software updates from the physician support device 4. Thephysician control device 2 may be configured to modify one or more ofits operational parameters automatically ((e.g., upon receipt of thesoftware update(s), once per week, once per month, etc.) or in responseto user input.

The vestibular stimulation device 1 may be configured to modify one ormore of its operational parameters responsive to receiving and/orretrieving one or more software updates from the physician supportdevice 4 and/or the physician control device 2. The vestibularstimulation device 1 may be configured to modify one or more of itsoperational parameters automatically ((e.g., upon receipt of thesoftware update(s), once per week, once per month, etc.) or in responseto user input. As shown in FIG. 43, in some embodiments, the vestibularstimulation system comprises, consists essentially of or consists of aregistry 5 operatively connected to a plurality of physician controldevices 2 a, 2 b wherein each of said plurality of physician controldevices 2 a, 2 b is operatively connected a plurality of vestibularstimulation devices 1 a, 1 b, 1 c, 1 d. In some embodiments, one or moreof the vestibular stimulation devices 1 a, 1 b, 1 c, 1 d is alsooperatively connected to the physician support device 4 via anindependent operative connection (i.e., independent of the physiciancontrol device 2 a, 2 b with which it is associated).

The registry 5 may be configured to store one or more thermal waveforms(e.g., one or more idealized thermal waveforms) in a database residingtherein (e.g., to store the parameters, indications and/or approvals ofthe thermal waveform(s) in a waveform database as described above)and/or to relay data associated with one or more thermal waveforms toone or more of the physician control devices 2 a, 2 b. The registry 5may be configured to transmit one or more thermal waveforms to thephysician control devices 2 a, 2 b over any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN, theInternet, a public telephone switching network, Bluetooth, WLAN and thelike. Likewise, each of the physician control devices 2 a, 2 b may beconfigured to access a waveform database residing in the registry 5 andto retrieve one or more thermal waveform(s) using any suitable wired orwireless communications channel, including, but not limited to, a LAN,the Internet, a public telephone switching network, Bluetooth, WLAN andthe like. Alternatively, one or more thermal waveform(s) may betransferred to the physician control devices 2 a, 2 b using a portablememory device, such as an SD memory card or a USB memory stick.

Each of the physician control devices 2 a, 2 b may be configured togenerate one or more thermal waveforms (i.e., to generate theparameters, indications and/or approvals of one or more thermalwaveforms) and/or to store the thermal waveform(s) in a database (e.g.,to store the parameters, indications and/or approvals of the thermalwaveform(s) in a waveform database as described above).

Each of the physician control devices 2 a, 2 b may be configured tomodify one or more of the thermal waveforms received/retrieved from theregistry 5 (i.e., to modify one or more of the parameters, indicationsand/or approvals of one or more thermal waveforms) and/or to store themodified thermal waveform(s) in a database (e.g., to store theparameters, indications and/or approvals of the modified thermalwaveform(s) in a waveform database as described above).

Each of the physician control devices 2 a, 2 b may be configured togenerate a plurality of prescriptions, each comprising a set ofinstructions for delivering one or more thermal waveforms to thevestibular system and/or the nervous system of a patient. In suchembodiments, one or more of the prescriptions may comprise a set ofinstructions for delivering one or more of the thermal waveformsgenerated by the physician support device 4 to the vestibular systemand/or the nervous system of a patient.

Each of the physician control devices 2 a, 2 b may be configured tostore one or more prescriptions in a database residing therein (e.g., aprescription database as described above) and/or to relay eachprescription to a vestibular stimulation device 1 a, 1 b, 1 c, 1 dassociated with the patient for whom the prescription was generated. Thephysician control devices 2 a, 2 b may be configured to transmit theprescriptions to the vestibular stimulation devices 1 a, 1 b, 1 c, 1 dover any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like. Likewise, each of the vestibularstimulation devices 1 a, 1 b, 1 c, 1 d may be configured to access aprescription database residing in the physician control device 2 a, 2 bwith which it is associated and to retrieve the prescriptions using anysuitable wired or wireless communications channel, including, but notlimited to, a LAN, the Internet, a public telephone switching network,Bluetooth, WLAN and the like. Alternatively, the prescriptions may betransferred to the vestibular stimulation devices 1 a, 1 b, 1 c, 1 dusing one or more portable memory devices, such as SD memory cardsand/or USB memory sticks.

Each of the vestibular stimulation devices 1 a, 1 b, 1 c, 1 d may beconfigured to deliver one or more prescribed thermal waveforms to thevestibular system and/or the nervous system of the patient for whom theprescription was generated. For example, as described above, eachvestibular stimulation device 1 a, 1 b, 1 c, 1 d may be configured todeliver the prescribed thermal waveform(s) the vestibular system and/orthe nervous system of the patient by activating one or more TEDs to warmand/or cool an earpiece inserted into an ear canal of the patient.

Each of the vestibular stimulation devices 1 a, 1 b, 1 c, 1 d may beconfigured to store feedback data in a database residing therein (e.g.,a feedback database as described above) and/or to relay feedback data tothe physician control device 2 a, 2 b with which it is associated and/orto the registry 5. Each of the vestibular stimulation devices 1 a, 1 b,1 c, 1 d may be configured to transmit feedback data to the physiciancontrol device 2 a, 2 b with which it is associated and/or to theregistry 5 over any suitable wired or wireless communications channel,including, but not limited to, a LAN, the Internet, a public telephoneswitching network, Bluetooth, WLAN and the like. Likewise, each of thephysician control devices 2 a, 2 b and/or to the registry 5 may beconfigured to access one or more feedback databases residing in thevestibular stimulation devices 1 a, 1 b, 1 c, 1 d and to retrievefeedback data using any suitable wired or wireless communicationschannel, including, but not limited to, a LAN, the Internet, a publictelephone switching network, Bluetooth, WLAN and the like.Alternatively, feedback data may be transferred to the physician controldevices 2 a, 2 b and/or to the registry 5 using a portable memorydevice, such as an SD memory card or a USB memory stick.

Each of the physician control devices 2 a, 2 b may be configured tosupplement feedback data received and/or retrieved from the vestibularstimulation device 1 a, 1 b, 1 c, 1 d with which it is associated withadditional feedback data (e.g., physician feedback data).

Each of the physician control devices 2 a, 2 b may be configured toanalyze feedback data received and/or retrieved from the vestibularstimulation device 1 a, 1 b, 1 c, 1 d with which it is associated. Forexample, the physician control devices 2 a, 2 b may be configured to usethe feedback data to identify waveform characteristics that may belinked to increased/decreased efficacy with regard to the treatment of agiven disease/disorder/injury, to identify modifications that are likelyto increase the effectiveness of a given thermal waveform, class ofthermal waveforms or combination of thermal waveforms; to identify newdiseases/disorders/injuries for which a given thermal waveform, class ofthermal waveforms, combination of thermal waveforms and/or treatmentregimen may provide an effective treatment; to predict which thermalwaveform(s) or combination(s) of thermal waveforms may be most effectivein treating a given disease/disorder/injury; to identify thermalwaveforms, classes of thermal waveforms and/or combinations of thermalwaveforms that are not likely to be effective in the treatment of agiven disease/disorder/injury, etc. In some embodiments, the feedbackmodule is configured to identify new idealized thermal waveforms byidentifying one or more diseases/disorders/injuries for which a thermalwaveform or class of waveforms is likely to be an effective treatment(e.g., by identifying a new thermal waveform that belongs to a class ofwaveforms known to be effective in treating one or morediseases/disorders/injuries), to identify one or more additionaldiseases/disorders/injuries for which a previously identified idealizedthermal waveform is likely to be an effective treatment (e.g., byidentifying, in a population of patients receiving treatment with anidealized thermal waveform for treatment of a firstdisease/disorder/injury, one or more co-morbiddiseases/disorders/injuries that also appear to be effectively treatedby the idealized thermal waveform) and/or to identify one or morediseases/disorders/injuries for which a previously identified idealizedthermal waveform is not likely to be an effective treatment (e.g., oneor more of the diseases/disorders/injuries for which an idealizedthermal waveform had previously been indicated and/or approved may beremoved from the list of indications for that thermal waveform or forthe class of thermal waveforms to which it belongs).

Each of the physician control devices 2 a, 2 b may be configured tostore feedback data (including any additional feedback data supplied bythe physician control devices 2 a, 2 b) in a database residing therein(e.g., a feedback database as described above) and/or to relay feedbackdata (including any additional feedback data supplied by the physiciancontrol devices 2 a, 2 b) to the registry 5. The physician controldevices 2 a, 2 b 2 may be configured to transmit feedback data to theregistry 5 over any suitable wired or wireless communications channel,including, but not limited to, a LAN, the Internet, a public telephoneswitching network, Bluetooth, WLAN and the like. Likewise, the registry5 may be configured to access one or more feedback databases residing inthe physician control devices 2 a, 2 b and to retrieve feedback datausing any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like. Alternatively, feedback data maybe transferred to the registry 5 using a portable memory device, such asan SD memory card or a USB memory stick.

Each of the physician control devices 2 a, 2 b may be configured tomodify one or more thermal waveforms responsive to analyzing feedbackdata received and/or retrieved from the vestibular stimulation deviceswith which it is associated 1 a, 1 b, 1 c, 1 d. For example, thephysician control devices 2 a, 2 b may be configured to modify one ormore parameters of the thermal waveform(s) received/retrieved from theregistry 5. The physician control devices 2 a, 2 b may be configured tomodify the thermal waveform(s) automatically (e.g., the physiciansupport device 4 may be configured to automatically modify one or morethermal waveforms if/when any of its analyses indicate that suchmodifications are likely to improve the efficacy of the thermalwaveform(s)) or responsive to user input.

Each of the physician control devices 2 a, 2 b may be configured tostore one or more modified thermal waveforms in a database residingtherein (e.g., a waveform database as described above) and/or to relaythe modified thermal waveform(s) to one or more of the vestibularstimulation devices 1 a, 1 b, 1 c, 1 d with which it is associatedand/or to the registry 5. The physician control devices 2 a, 2 b may beconfigured to transmit one or more modified thermal waveforms to one ormore of the physician control devices 2 a, 2 b and/or the registry 5over any suitable wired or wireless communications channel, including,but not limited to, a LAN, the Internet, a public telephone switchingnetwork, Bluetooth, WLAN and the like. Likewise, each of the vestibularstimulation devices 1 a, 1 b, 1 c, 1 d and/or the registry 5 may beconfigured to access a waveform database residing in one or more of thephysician control devices 2 a, 2 b and to retrieve the modified thermalwaveform(s) using any suitable wired or wireless communications channel,including, but not limited to, a LAN, the Internet, a public telephoneswitching network, Bluetooth, WLAN and the like. Alternatively, themodified thermal waveform(s) may be transferred to the vestibularstimulation devices 1 a, 1 b, 1 c, 1 d with which it is associatedand/or the registry 5 using a portable memory device, such as an SDmemory card or a USB memory stick.

Each of the physician control devices 2 a, 2 b may be configured tomodify one or more prescriptions responsive to analyzing feedback datareceived and/or retrieved from the vestibular stimulation device 1 a, 1b, 1 c, 1 d with which it is associated and/or to modifying one or moremodified thermal waveforms. For example, the physician control devices 2a, 2 b may be configured to modify one or more parameters of aprescription stored in a prescription database residing therein. Thephysician control devices 2 a, 2 b may be configured to modify theprescription(s) automatically (e.g., the physician control devices 2 a,2 b may be configured to automatically modify one or more prescriptionsif/when any of its analyses indicate that such modifications are likelyto improve the efficacy of the prescription(s)) or responsive to userinput.

Each of the physician control devices 2 a, 2 b may be configured tostore one or more modified prescriptions in a database residing therein(e.g., a waveform database as described above) and/or to relay themodified thermal waveform(s) to the vestibular stimulation device 1 a, 1b, 1 c, 1 d with which it is associated and/or to the registry 5. Thephysician control devices 2 a, 2 b may be configured to transmit one ormore modified prescriptions to the vestibular stimulation device 1 a, 1b, 1 c, 1 d and/or the registry 5 with which it is associated over anysuitable wired or wireless communications channel, including, but notlimited to, a LAN, the Internet, a public telephone switching network,Bluetooth, WLAN and the like. Likewise, each of the vestibularstimulation devices 1 a, 1 b, 1 c, 1 d and/or the registry 5 may beconfigured to access a prescription database residing in the physiciancontrol device 2 a, 2 b with which it is associated and to retrieve themodified prescription(s) using any suitable wired or wirelesscommunications channel, including, but not limited to, a LAN, theInternet, a public telephone switching network, Bluetooth, WLAN and thelike. Alternatively, the modified prescription(s) may be transferred tothe vestibular stimulation devices 1 a, 1 b, 1 c, 1 d and/or theregistry 5 using a portable memory device, such as an SD memory card ora USB memory stick.

Each of the vestibular stimulation devices 1 a, 1 b, 1 c, 1 d may beconfigured to deliver one or more thermal waveforms to the vestibularsystem and/or the nervous system of the patient in accordance with oneor more modified prescriptions to the vestibular system and/or thenervous system of a patient. For example, as described above, thevestibular stimulation devices 1 a, 1 b, 1 c, 1 d may be configured todeliver the prescribed thermal waveform(s) the vestibular system and/orthe nervous system of the patient by activating one or more TEDs to warmand/or cool an earpiece inserted into an ear canal of the patient.

The registry 5 may be configured to generate one or more softwareupdates. Each software update may comprise, consist essentially of orconsist of a set of instructions for modifying one or more operationalparameters one or more of the vestibular stimulation devices 1 a, 1 b, 1c, 1 d and/or one or more of the physician control devices 2 a, 2 b.

The registry 5 may be configured to store one or more software updatesin a database residing therein and/or to relay one or more softwareupdates to one or more of the vestibular stimulation devices 1 a, 1 b, 1c, 1 d and/or one or more of the physician control devices 2 a, 2 b. Thephysician support device 4 may be configured to transmit one or moresoftware updates to the vestibular stimulation devices 1 a, 1 b, 1 c, 1d and/or the physician control devices 2 a, 2 b over any suitable wiredor wireless communications channel, including, but not limited to, aLAN, the Internet, a public telephone switching network, Bluetooth, WLANand the like. Likewise, each of the vestibular stimulation devices 1 a,1 b, 1 c, 1 d and/or each of the physician control devices 2 a, 2 b maybe configured to access a database residing in the registry 5 and toretrieve one or more software updates using any suitable wired orwireless communications channel, including, but not limited to, a LAN,the Internet, a public telephone switching network, Bluetooth, WLAN andthe like. Alternatively, one or more software updates may be transferredto the vestibular stimulation devices 1 a, 1 b, 1 c, 1 d and/or thephysician control devices 2 a, 2 b using a portable memory device, suchas an SD memory card or a USB memory stick. The software update(s) maybe relayed from the registry 5 to the vestibular stimulation devices 1a, 1 b, 1 c, 1 d and/or the physician control devices 2 a, 2 bautomatically (e.g., upon generation, once per week, once per month,etc.) or in response to user input.

Each of the physician control devices 2 a, 2 b may be configured tostore one or more software updates in a database residing therein and/ortransmit one or more software updates to one or more of the vestibularstimulation devices 1 a, 1 b, 1 c, 1 d with which it is associated. Thephysician control devices 2 a, 2 b may be configured to transmit thesoftware update(s) to one or more of the vestibular stimulation devices1 a, 1 b, 1 c, 1 d with which it is associated over any suitable wiredor wireless communications channel, including, but not limited to, aLAN, the Internet, a public telephone switching network, Bluetooth, WLANand the like. Likewise, each of the vestibular stimulation devices 1 a,1 b, 1 c, 1 d may be configured to access a database residing in thephysician control device 2 a, 2 b with which it is associated and toretrieve one or more software updates using any suitable wired orwireless communications channel, including, but not limited to, a LAN,the Internet, a public telephone switching network, Bluetooth, WLAN andthe like. Alternatively, one or more software updates may be transferredto the vestibular stimulation devices 1 a, 1 b, 1 c, 1 d using aportable memory device, such as an SD memory card or a USB memory stick.

Each of the physician control devices 2 a, 2 b may be configured tomodify one or more of its operational parameters responsive to receivingand/or retrieving one or more software updates from the registry 5. Thephysician control devices 2 a, 2 b may be configured to modify one ormore of its operational parameters automatically ((e.g., upon receipt ofthe software update(s), once per week, once per month, etc.) or inresponse to user input.

Each of the vestibular stimulation devices 1 a, 1 b, 1 c, 1 d may beconfigured to modify one or more of its operational parametersresponsive to receiving and/or retrieving one or more software updatesfrom the registry 5 and/or the physician control device 2 a, 2 b withwhich it is associated. The vestibular stimulation devices 1 a, 1 b, 1c, 1 d may be configured to modify one or more of its operationalparameters automatically ((e.g., upon receipt of the software update(s),once per week, once per month, etc.) or in response to user input.

As shown in FIG. 44, in some embodiments, the vestibular stimulationsystem comprises, consists essentially of or consists of a registry 5, aphysician control device 2 and a vestibular stimulation device 1comprising a controller 11, a pair of earpieces 12 a, 12 b, a pair ofTEDs 13 a, 13 b and a pair of sensors 14 a, 14 b, wherein each of theTEDs 13 a, 13 b is operatively connected to the controller 11 via athermal stimulation lead 16 a, 16 b and thermally connected to one ofthe earpieces 12 a, 12 b and wherein each of the sensors 14 a, 14 b isoperatively connected to the controller 11 via a wireless connection 17a, 17 b and thermally connected to one of the earpieces 12 a, 12 b. Insome such embodiments, the registry 5 comprises a network module 4 d, awaveform database 4 h, a prescription database 4 i, a feedback database4 j and a patient history database 4 k; the physician control device 2comprises a waveform module 2 a, a treatment module 2 b, a networkmodule 2 d, a feedback module 2 f, a waveform database 2 h, aprescription database 2 i, a feedback database 2 j and a patient historydatabase 2 k and the controller comprises a control module 11 c, anetwork module 11 d, a feedback module 11 f, a prescription database 11i and a feedback database 11 j.

The registry 5 may be configured to relay one or more thermal waveforms(e.g., idealized thermal waveforms) to the physician control device 2(i.e., data associated with the parameters, indications and/or approvalsof one or more thermal waveforms may be transferred from the registry 5to the physician control device 2). For example, the registry 5 may beconfigured such that the thermal waveform(s) are transmitted directly tothe physician control device 2 by the network module 5 d residing in theregistry 5 and/or are stored in the waveform database 5 h residing inthe registry 5, from whence they may subsequently be transmitted toand/or retrieved by the physician control device 2.

The network module 2 d residing in the physician control device 2 may beconfigured to receive and/or retrieve one or more thermal waveforms fromthe physician registry 5 and to relay the thermal waveforms to thetreatment module 2 b and/or to the waveform database 2 h residing in thephysician control device 2, from whence they may subsequently betransmitted to and/or retrieved by the treatment module 2 b.

The waveform module 2 a may be configured to modify one or more of thethermal waveforms received/retrieved from the registry 5 (i.e., tomodify one or more of the parameters, indications and/or approvals ofone or more of the thermal waveforms received/retrieved from theregistry 5). The physician control device 2 may be configured such thatthe modified thermal waveforms generated by the waveform module 4 a aretransmitted directly to the treatment module 2 b by the network module 2d residing in the physician control device 2 and/or are stored in thewaveform database 2 h residing in the physician control device 2, fromwhence they may subsequently be transmitted to and/or retrieved by thetreatment module 2 b.

The treatment module 2 b may be configured to retrieve one or more ofthe thermal waveforms received/retrieved from the registry 5 and/or oneor more of the modified thermal waveforms generated by the waveformmodule 2 a from the waveform database 2 h residing in the physiciancontrol device 2 and/or from the waveform database 5 h residing in theregistry 5.

The treatment module 2 b may be configured to generate a prescriptioncomprising a set of instructions for delivering one or more of thethermal waveforms received/retrieved from the registry 5 and/or one ormore of the modified thermal waveforms generated by the waveform module2 a to the vestibular system and/or the nervous system of a patient. Thephysician control device 2 may be configured such that the prescriptiongenerated by the treatment module 2 b is transmitted directly to thevestibular stimulation device 1 and/or the registry 5 by the networkmodule 2 d residing in the physician control device 2 and/or is storedin the prescription database 2 i residing in the physician controldevice 2, from whence it may subsequently be transmitted to and/orretrieved by the vestibular stimulation device 1 and/or the registry 5.

The network module 5 d residing in the registry 5 may be configured toreceive and/or retrieve the prescription from the physician controldevice 2 and to relay the prescription to the prescription database 5 iresiding in the registry 5.

The network module 11 d residing in the controller 11 may be configuredto receive and/or retrieve the prescription from the physician controldevice 2 and to relay the prescription to the control module 11 c and/orto the prescription database 11 i residing in the controller 11.

The control module 11 c may be configured to retrieve the prescriptionfrom the prescription database 11 i residing in the controller 11.

The control module 11 c may be configured to deliver the prescribedthermal waveform(s) by activating the TEDs 13 a, 13 b in accordance withthe prescription (i.e., by activating the TEDs 13 a, 13 b to by warmand/or cool the earpieces 12 a, 12 b so as to deliver the prescribedthermal waveform(s)).

The feedback module 11 f residing in the controller 11 may be configuredto receive feedback data from the TEDs 13 a, 13 b and/or the sensors 14a, 14 b (e.g., data associated with the temperature of the earpieces 12a, 12 b, the temperature of the patient's ear canals, the impedancebetween the earpieces 12 a, 12 b, etc.). The controller 11 may beconfigured such that the feedback data received by the feedback module11 f is transmitted directly to the physician control device 2 and/orthe registry 5 by the network module 11 d residing in the controller 11and/or is stored in the feedback database 11 j residing in thecontroller 11, from whence it may subsequently be transmitted to and/orretrieved by the physician control device 2 and/or the registry 5.

The network module 2 d residing in the physician control device 2 may beconfigured to receive and/or retrieve feedback data from the vestibularstimulation device 1 and to relay the feedback data to the registry 5,to the feedback module 2 f residing in the physician control device 2and/or to the feedback database 2 j residing in the physician controldevice 2, from whence they may subsequently be transmitted to and/orretrieved by the registry 5 and/or the feedback module 2 f residing inthe physician control device 2.

The physician control device 2 may be configured to supplement thefeedback data received and/or retrieved from the vestibular stimulationdevice 1 with additional feedback data (e.g., physician commentsregarding the effectiveness of a given thermal waveform, class ofthermal waveforms, combination of thermal waveforms, etc.) and to relaythe additional feedback data to the registry 5, to the feedback module 2f residing in the physician control device 2 and/or to the feedbackdatabase 2 j residing in the physician control device 2, from whencethey may subsequently be transmitted to and/or retrieved by the registry5 and/or the feedback module 2 f residing in the physician controldevice 2.

The feedback module 2 f residing in the physician control device 2 maybe configured to retrieve feedback data (including any additionalfeedback data supplied by the physician control device 2) from thefeedback database 2 j residing in the physician control device 2.

The feedback module 2 f residing in the physician control device 2 maybe configured to analyze the feedback data (e.g., to estimate thethermal contact between each of the earpieces 12 a, 12 b and thepatient's ear canals, to calculate patient-specific time constants, toevaluate the precision with the prescribed thermal waveform(s) wasdelivered, etc.). The physician control device 2 may be configured suchthat data associated with the feedback module's 2 f analysis aretransmitted to the registry 5 and/or to the feedback database 2 jresiding in the physician control device 2, from whence they maysubsequently be transmitted to and/or retrieved by the registry 5.

The network module 5 d residing in the registry 5 may be configured toreceive and/or retrieve feedback data (including any additional feedbackdata supplied by the physician control device 2 and/or data associatedwith any analysis performed by the feedback module 2 f residing in thephysician control device 2) from the physician control device 2 and torelay the feedback data to the feedback database 5 j residing in theregistry 5.

The waveform module 2 a may be configured to modify one or more of thethermal waveforms responsive to receiving and/or retrieving dataassociated with the feedback module's 2 f analysis (e.g., by modifyingone or more of the parameters, indications and/or approvals of a thermalwaveform). The waveform module 2 a may be configured to modify thethermal waveform(s) automatically (e.g., the waveform module 2 a may beconfigured to periodically check the feedback database 2 j for newanalyses and to automatically modify one or more thermal waveformsif/when any analysis performed by the feedback module 2 f indicates thatsuch modifications are likely to improve the efficacy of the thermalwaveform(s)) or responsive to user input. The physician control device 2may be configured such that any modifications made by the waveformmodule 2 a are transmitted to the registry 5 and/or the waveformdatabase 2 h residing in the physician control device 2, from whencethey may subsequently be transmitted to and/or retrieved by the registry5.

The treatment module 2 b may be configured to retrieve data associatedwith the feedback module's 2 f analysis from the feedback database 2 jresiding in the physician control device 2 and/or to retrieve anymodifications made by the waveform module 2 a from the waveform database2 h residing in the physician control device 2 and/or from the waveformdatabase residing in the registry 5.

The network module 5 d residing in the registry 5 may be configured toreceive and/or retrieve one or more modified thermal waveforms from thephysician control device 2 and to relay the modified thermal waveform(s)to the waveform database 5 h residing in the registry 5.

The treatment module 2 b may be configured to modify, update and/orextend the prescription responsive to receiving and/or retrieving dataassociated with the feedback module's 2 f analysis and/or to receivingand/or retrieving any modifications made by the waveform module 2 a. Thetreatment module 2 b may be configured to modify, update and/or extendthe prescription automatically (e.g., the treatment module 2 b may beconfigured to periodically check the waveform database 2 h for updatesand to automatically modify the prescription if/when one or more of theparameters, indications or approvals of a thermal waveform used in theprescription has been modified by the waveform module 4 a) or responsiveto user input. The physician control device 2 may be configured suchthat any modifications made by the treatment module 2 b are relayed tothe vestibular stimulation device 1 as described above and/or aretransmitted to the registry 5 and/or the prescription database 2 iresiding in the physician control device 2, from whence they maysubsequently be transmitted to and/or retrieved by the registry 5.

The network module 5 d residing in the registry 5 may be configured toreceive and/or retrieve one or more modified prescriptions from thephysician control device 2 and to relay the modified prescription(s) tothe prescription database 5 i residing in the registry 5.

The physician control device 2 may be configured to generate and/ormodify patient information (e.g., information related to a patient'sidentity, medical history, current symptoms, current prescriptions,etc.). The physician control device 2 may be configured to transmitpatient information to the registry 5 and/or to the patient historydatabase 2 k residing in the physician control device 2, from whence itmay subsequently be transmitted to and/or retrieved by the registry 5.

The network module 5 d residing in the registry 5 may be configured toreceive and/or retrieve patient information from the physician controldevice 2 and to relay the patient information to the patient historydatabase 5 k residing in the registry 5.

One of skill in the art will appreciate that one or more telemedicinemodules may be incorporated into the vestibular stimulation systemsdescribed above to facilitate and/or control communications between thevestibular stimulation devices, patient control devices, physiciancontrol devices, physician support devices and/or registries. Forexample, a first telemedicine module may be operatively connected to aphysician control device to ensure that prescriptions transmitted to avestibular stimulation device comply with patient privacy regulationsand a second telemedicine module may be operatively connected to thevestibular stimulation device to ensure that feedback data transmittedto the physician control device likewise comply with patient privacyregulations. Similarly, a first telemedicine module may be operativelyconnected to a physician control device to ensure that feedback datatransmitted to a physician support device comply with patient privacyregulations and a second telemedicine module may be operativelyconnected to the physician support device to ensure that any analysistransmitted to the physician control device likewise complies withpatient privacy regulations.

Delivering Thermal Waveforms

As noted above, the present invention provides a method of deliveringone or more thermal waveforms (e.g., one or more actively controlled,time-varying thermal waveforms) to the vestibular system and/or thenervous system of a patient.

In some embodiments, the method comprises, consists essentially of orconsists of generating a prescription comprising a set of instructionsfor delivering one or more thermal waveforms to the vestibular systemand/or the nervous system of a patient and delivering the prescribedthermal waveform(s) to the patient using a vestibular stimulationdevice. Any suitable vestibular stimulation device may be used todeliver the prescribed thermal waveform(s), including, but not limitedto, a vestibular stimulation device as described above. In someembodiments, the prescription comprises a set of instructions fordelivering one or more thermal waveforms to the left ear canal of apatient and for delivering one or more thermal waveforms to the rightear canal of a patient.

In some embodiments, the prescription is generated and delivered usingthe same vestibular stimulation device.

In some embodiments, the prescription is generated by a physiciancontrol device and delivered using a vestibular stimulation device. Anysuitable physician control device may be used to generate theprescription, including, but not limited to, a physician control deviceas described above. As shown in FIG. 45, in such embodiments, the methodmay comprise generating a prescription comprising a set of instructionsfor the delivery of one or more thermal waveforms to the vestibularsystem and/or the nervous system of a patient 1000, transmitting theprescription to a vestibular stimulation device 1010 and delivering theprescribed thermal waveform(s) using the vestibular stimulation device1020. The prescription may be transmitted to the vestibular stimulationdevice directly from the physician control device that generated theprescription or via an intermediate device (e.g., a patient controldevice or a telemedicine module, as described above). As discussedabove, the prescription may be transmitted to the vestibular stimulationdevice over any suitable wired or wireless communications channel,including, but not limited to, a LAN, the Internet, a public telephoneswitching network, Bluetooth, WLAN and the like. Alternatively, theprescription may be uploaded to the vestibular stimulation device usinga portable memory device, such as an SD memory card or a USB memorystick.

In some embodiments, the method comprises generating one or more thermalwaveforms. Thermal waveforms may be generated using any suitable means,including, but not limited to, a waveform module as described above. Forexample, a physician support device as described above may be used togenerate the parameters, indications and/or approvals of one or morethermal waveforms (e.g., idealized thermal waveforms).

In some embodiments, the method comprises modifying one or more thermalwaveforms. Thermal waveforms may be modified using any suitable means,including, but not limited to, a waveform module as described above. Forexample, a physician support device as described above may be used tomodify the parameters, indications and/or approvals of one or morethermal waveforms (e.g., idealized thermal waveforms).

In some embodiments, the method comprises storing one or more thermalwaveforms in a database. Thermal waveforms may be stored in any suitabledatabase, including, but not limited to, a waveform database asdescribed above. For example, one or more thermal waveforms may bestored in a waveform database residing in a physician support device asdescribed above, a waveform database residing in a physician controldevice as described above and/or a waveform database residing in aportable memory device (e.g., an SD memory card).

In some embodiments, the method comprises updating a waveform database.The waveform database may be updated using any suitable means,including, but not limited to, a waveform module as described above. Thewaveform database may be updated automatically. The waveform databasemay be updated at any suitable interval (e.g., daily, weekly, monthly,etc.). For example, a waveform database residing in a physician supportdevice as described above may be automatically updated in response toanalyses performed by a feedback module residing in the physiciansupport device.

In some embodiments, the method comprises selecting one or more thermalwaveforms. Thermal waveforms may be selected using any suitable means,including, but not limited to, a treatment module as described above.Thermal waveforms may be selected from any suitable source, including,but not limited to, a waveform database as described above. For example,a physician control device as described above may be used to select oneor more thermal waveforms (e.g., idealized thermal waveforms) from awaveform database residing in the physician control, a waveform databaseresiding in a physician support device as described above and/or awaveform database residing in a portable memory device (e.g., an SDmemory card).

In some embodiments, the method comprises generating one or moreinstructions for delivering one or more thermal waveforms to thevestibular system and/or the nervous system of a patient. Instructionsfor delivering one or more thermal waveforms to the vestibular systemand/or the nervous system of a patient may be generated using anysuitable means, including, but not limited to, a treatment module asdescribed above. For example, a physician control device as describedabove may be used to generate instructions as to which thermalwaveform(s) is/are to be delivered to the patient, when each thermalwaveform is to be delivered to the patient, whether each thermalwaveform is to be delivered to the right and/or the left ear canal ofthe patient, how long the treatment schedule is to last, how manytreatments may be administered in a given day/week/month, etc.

In some embodiments, the method comprises modifying instructions fordelivering one or more thermal waveforms to the vestibular system and/orthe nervous system of a patient. Instructions for delivering one or morethermal waveforms to the vestibular system and/or the nervous system ofa patient may be modified using any suitable means, including, but notlimited to, a treatment module as described above. For example, aphysician control device as described above may be used to modify whichthermal waveform(s) is/are to be delivered to a patient, when eachthermal waveform is to be delivered to the patient, whether each thermalwaveform is to be delivered to the right and/or the left ear canal ofthe patient, how long the treatment schedule is to last, how manytreatments may be administered in a given day/week/month, etc.

In some embodiments, the method comprises storing one or moreinstructions for delivering one or more thermal waveforms to thevestibular system and/or the nervous system of a patient. Instructionsfor delivering one or more thermal waveforms to the vestibular systemand/or the nervous system of a patient may be stored in any suitabledatabase, including, but not limited to, a prescription database asdescribed above. For example, one or more instructions for deliveringone or more thermal waveforms to the vestibular system and/or thenervous system of a patient may be stored in a prescription databaseresiding in a physician support device as described above, aprescription database residing in a physician control device asdescribed above and/or a prescription database residing in a portablememory device (e.g., an SD memory card).

In some embodiments, the method comprises selecting one or moreinstructions for delivering one or more thermal waveforms to thevestibular system and/or the nervous system of a patient. Instructionsfor delivering one or more thermal waveforms to the vestibular systemand/or the nervous system of a patient maybe selected from any suitablesource, including, but not limited to, a prescription database asdescribed above. For example, a physician control device as describedabove may be used to select one or more instructions for delivering oneor more thermal waveforms to the vestibular system and/or the nervoussystem of a patient from a prescription database residing in thephysician control, a prescription database residing in a physiciansupport device as described above and/or a prescription databaseresiding in a portable memory device (e.g., an SD memory card).

In some embodiments, generating a prescription comprises receiving userinput and generating a prescription responsive to said user input. Userinput may include, but is not limited to, selection of one or morethermal waveform parameters (e.g., shape, frequency, amplitude,duration, etc.), selection of one or more thermal waveforms from adatabase (e.g., a waveform database residing in the device used togenerate the prescription), modification of one or more thermal waveformparameters, generation of one or more instructions for delivering one ormore thermal waveforms to the vestibular system and/or the nervoussystem of a patient, modification of one or more instructions fordelivering one or more thermal waveforms to the vestibular system and/orthe nervous system of a patient and selection of one or moreinstructions for delivering one or more thermal waveforms to thevestibular system and/or the nervous system of a patient. Any suitablemeans may be used to receive user input, including, but not limited to,a GUI module as described above.

In some embodiments, the method further comprises monitoring thepatient's response to the prescribed thermal waveform(s), modifying theprescription based upon the patient's response to the prescribed thermalwaveform(s) and delivering one or more thermal waveforms to thevestibular system and/or the nervous system of the patient in accordancewith the modified prescription. The prescription may be modified in anysuitable manner, including, but not limited to, adding/deleting thermalwaveforms, changing one or more of the parameters (e.g., shape,frequency, amplitude, duration, etc.) the prescribed thermal waveform(s)and changing one or more of the parameters of delivery (e.g., how ofteneach of the prescribed thermal waveforms is delivered, what time of dayeach of the thermal waveforms is delivered, etc.).

In some such embodiments, the prescription is modified by a physiciancontrol device and delivered using a vestibular stimulation device. Anysuitable physician control device may be used to generate theprescription, including, but not limited to, a physician control deviceas described above. As shown in FIG. 46, the method may generating aprescription comprising a set of instruction for the delivery of one ormore thermal waveforms to the vestibular system and/or the nervoussystem of a patient 1000, transmitting the prescription to a vestibularstimulation device 1010, delivering the prescribed thermal waveform(s)to the vestibular system and/or the nervous system of the patient usingthe vestibular stimulation device 1020, monitoring the patient'sresponse to the prescribed thermal waveform(s) 1030, modifying theprescription based upon the patient's response to the prescribed thermalwaveform(s) 1040, delivering the modified prescription to the vestibularstimulation device 1050 and delivering one or more thermal waveforms tothe vestibular system and/or the nervous system of the patient using thevestibular stimulation and/or the nervous system of the patientaccording to the modified prescription 1060.

In some embodiments, the method further comprises monitoring thepatient's response to the thermal waveform(s) delivered according to themodified prescription, modifying the prescription based upon thepatient's response to the thermal waveform(s) delivered according to themodified prescription and delivering one or more thermal waveforms tothe vestibular system and/or the nervous system of the patient inaccordance with the newly-modified prescription. Such monitoring andmodification may be performed as often as is feasible and/or desired.

Updating a Waveform Database

As noted above, the present invention provides a method of updating adatabase comprising one or more thermal waveforms (e.g., idealizedthermal waveforms).

In some embodiments, the method comprises analyzing data (e.g., dataassociated with the delivery of one or more thermal waveforms, patientfeedback data, physician feedback data and patient information) andupdating a waveform database responsive to said analysis. In someembodiments, the method comprises modifying one or more parameters,indications and/or approvals of one or more thermal waveforms (e.g.,idealized thermal waveforms) responsive to analyzing data associatedwith the delivery of one or more thermal waveforms. In some embodiments,the method comprises modifying one or more parameters, indicationsand/or approvals of one or more thermal waveforms (e.g., idealizedthermal waveforms) responsive to analyzing patient feedback data. Insome embodiments, the method comprises modifying one or more parameters,indications and/or approvals of one or more thermal waveforms (e.g.,idealized thermal waveforms) responsive to analyzing physician feedbackdata. In some embodiments, the method comprises modifying one or moreparameters, indications and/or approvals of one or more thermalwaveforms (e.g., idealized thermal waveforms) responsive to analyzingpatient information.

Analyzing data may comprise the analysis of data from any suitablesource, including, but not limited to, a feedback database as describedabove and a patient history database as described above. For example,analyzing data may comprise the analysis of data from a feedbackdatabase residing in a vestibular stimulation device as described above,a feedback database residing in a patient control device as describedabove, a feedback database residing in a physician control device asdescribed above, a feedback database residing in a physician supportdevice as described above, a feedback database residing in a portablememory device (e.g., an SD memory card), a patient history databaseresiding in a vestibular stimulation device as described above, apatient history database residing in a patient control device asdescribed above, a patient history database residing in a physiciancontrol device as described above, a patient history database residingin a physician support device as described above and a patient historydatabase residing in a portable memory device (e.g., an SD memory card).

Any suitable analysis may be carried out, including, but not limited to,identifying waveform modifications that are likely to increase theeffectiveness of a given thermal waveform, class of thermal waveforms orcombination of thermal waveforms; identifying newdiseases/disorders/injuries for which a given thermal waveform, class ofthermal waveforms, combination of thermal waveforms and/or treatmentregimen may provide an effective treatment; predicting which thermalwaveform(s) may be most effective in treating a givendisease/disorder/disorder (in patients of a given age, sex, etc., forexample); identifying thermal waveforms, classes of thermal waveformsand/or combinations of thermal waveforms that are not likely to beeffective in the treatment of a given disease/disorder/injury; identifywaveform characteristics that may be linked to increased/decreasedefficacy with regard to the treatment of a givendisease/disorder/injury.

In some embodiments, the waveform database is automatically updated inresponse to analysis of data associated with the delivery of one or morethermal waveforms, patient feedback data, physician feedback data and/orpatient information (i.e., no user input is required to trigger theupdate).

The database may be updated by adding one or more thermal waveforms,modifying the parameters (e.g., shape, frequency, amplitude andduration), indications and/or approvals of one or more of the thermalwaveforms in the database and/or deleting one or more of the thermalwaveforms from the database.

The present invention is explained in greater detail in the followingnon-limiting Examples.

Example 1 Long Duration Square Wave Administration

A male subject in his forties and good health, naïve to CVS, wasadministered cold CVS to his right ear in a square waveform pattern. Thepattern was of cooling to 10 degrees Centigrade (as compared to normalbody temperature of about 37 degrees Centigrade) as a “step” function or“square wave” with one symmetric square wave being delivered for a timeperiod of 20 minutes. The subject was observed by others to be slurringhis words, and was asked to remain seated for a time of two hoursfollowing the treatment session as a precaution. Otherwise, no long-termdeleterious effects were observed.

Example 2 Sawtooth Wave Administration

The same subject described in EXAMPLE 1 was subsequently treated byadministering cold CVS to the right ear in a sawtooth waveform patternof cooling to 20 degrees Centigrade (as compared to normal bodytemperature of about 37 degrees Centigrade) in a symmetric sawtoothwaveform pattern, without gaps, at a frequency of one cycle or waveformevery five minutes, for a total duration of approximately 10 minutes anda delivery of a first and second waveform. Unlike the situation with thesquare wave pattern described in Example 1, the subject continued toperceive the temperature cycling up and down.

Example 3 Maximum Waveform Amplitude

The same subject described in Examples 1-2 was administered cold CVS tothe right ear as a sawtooth cooling waveform at different amplitudes ina titration study. A maximum perceived sensation of cyclic cooling wasperceived at a peak amplitude of about 17 degrees Centigrade (or coolingfrom normal body temperature to a temperature of about 20 degreesCentigrade). Cooling beyond this did not lead to additional gains in thesensation of cyclic cooling perceived by the subject.

Example 4 Minimum Waveform Amplitude

Modeling of the human vestibular system indicates that the cupula (thestructure within the semicircular canals pushed by the movement of fluidtherein and which contain hair cells that convert the mechanicaldistortion to electrical signals in the vestibular nerve), is stimulatedby CVS at chilling temperatures of 5 or 7 degrees Centigrade below bodytemperature.

Example 5 Maximum Waveform Frequency

Modeling of the human vestibular system indicates that a slew ratefaster than 20 degrees Centigrade per minute (which would enable one 20degree Centigrade waveform every two minutes) is not useful because thehuman body cannot adapt to temperature changes at a more rapid rate.While maximum frequency is dependent in part on other factors such aswaveform amplitude, a maximum frequency of about one cycle every one totwo minutes is indicated.

Example 6 Minimum Waveform Frequency

Modeling of the human vestibular system indicates that a continuous,time-varying waveform is most effective in stimulating the vestibularsystem, as stagnation and adaptation of the cupula is thereby minimized.While minimum frequency is dependent in part on other factors such asthe waveform amplitude, a minimum frequency of about one cycle every tento twenty minutes is indicated.

Example 7 Treatment Session Duration

To permit delivery of at least a first and second waveform, a durationof at least one or two minutes is preferred. As noted above and below,results have been reported by patients with treatment durations of tenand twenty minutes. Hence, as a matter of convenience, a treatmentsession duration of not more than 30 or 40 minutes is preferred (thoughlonger sessions may be desired for some conditions, such as acute caresituations).

Example 8 Treatment of Migraine Headache with Sawtooth Waveforms

A female patient in her early fifties with a long standing history ofmigraine suffered an acute migraine episode with symptoms that consistedof a pounding headache, nausea, phonophobia, and photophobia. Right earcold CVS was performed using the sawtooth waveform, essentially asdescribed in Example 2 above, with a temperature maximum of 17 degreesCentigrade (chilling from body temperature) for 10 minutes (for a totaldelivery of two cycles). At the conclusion of the treatment the patientreported that her headache and associated symptoms were no longerpresent. At a reassessment one day later, the patient reported that theheadache had not returned.

Example 9 Treatment of Diabetes with Sawtooth Waveforms

The same subject described in examples 1-3 suddenly developed an episodeof extreme urination (10 liters per day), thirst for ice water, andassociated fatigue. Urinary testing suggested the onset of diabetesmellitus, for which there was strong family history.

The patient's initial weight as taken at his primary care physicianindicated a recent 20 pound weight loss. The first attempt to obtain aglucose reading from the patient resulted in an out of range result(this result typically occurs with glucose levels in excess of 600mg/dl). The patient was hospitalized and received hydration and IVinsulin therapy. The patient's first glucose level after this treatmentwas 700 mg/dl. The glucose level were brought down to approximately 350and treatment with an oral antihyperglycemic agent was initiated.

Follow-up care after hospital discharge with the subject's primary carephysican expanded the oral antihyperglycemic agent therapy to includeboth metformin and JANUVIA™ sitagliptin. In addition, a strict exerciseprogram of 30-45 minutes 5 to 6 days per week and diet control wereinstituted. Daily glucose levels via finger stick were taken 2 to 3times per day.

At this point the patient's baseline hemoglobin A1c (Hb A1c) level was9.8%, as compared to normal levels of 5 to 6%.

The patient then began daily treatment with CVS. The treatment wascarried out for a time of ten minutes, once a day for about a month,after which the treatment was continued two to three times a week forthree additional months (with each treatment session being about 10minutes in duration). The CVS was delivered to the patient's right ear,as a sawtooth cooling waveform as described in Example 2. At theconclusion of these treatments, the patient's BB A1c level was 5.3%. Asa result, the patient was removed from all hypoglemic agents.

Most oral antihyperglycemic agents lower a patient's Hb A1c level byapproximately 1 to 2% (see generally S. Inzucchi, Oral AntihyperglycemicTherapy for Type 2 Diabetes, JAMA 287:360-372 (Jan. 16, 2002)). Incontrast, this patient's initial value was 9.5, and dropped to 5.3.

Example 10 Alternate Waveform Shapes

The sawtooth waveform described in the examples above was symmetric andlinear, as illustrated in FIG. 47A, where line dashed line “n”represents the subject's normal body temperature (typically about 37degrees Centigrade). Modeling of the vestibular system indicates thatwaveforms of similar amplitude and frequency, but with a variation inshape, are also effective, such as the “logarithmic” or “convex”waveform of FIG. 47B, and the “exponential” or “concave” waveform ofFIG. 47C. All waveforms generally include a leading edge (“le”), atrailing edge (“te”), a peak (“p”) and a trough (“t”).

While FIGS. 47A through 47C all show three consecutive waveforms of thesame shape, amplitude, and frequency, the consecutive waveforms can bevaried in shape as shown in FIG. 47D, and can be varied in amplitude orduration as well (preferably each consecutive waveform within theparameters noted above), to produce still additional waveforms andsequences of waveforms which are useful in carrying out the presentinvention.

In addition, while the waveforms of FIGS. 47A through 47D are shown ascontinuous, minor disruptions can be included therein, such astruncations (“trn”; for example, as shown in FIG. 47E) or vertical cuts(“ct”; for example, as shown in FIG. 47F) to produce still additionalwaveforms and sequences of waveforms which are useful in carrying outthe present invention.

The peak for all waveforms of FIGS. 47A-47F is cooling by 17 degreesCentigrade from normal body temperature to a temperature of 20 degreesCentigrade, and the trough for all waveforms is a return to normal bodytemperature, giving an amplitude of 17 degrees Centigrade. The frequencyfor all illustrated waveforms is 1 cycle (or one complete waveform)every five minutes. While 3 cycles of the same waveform are illustratedfor clarity, note that in some of the examples above only two cycles aredelivered over a total treatment or session duration of ten minutes.

Example 11 Patient Orientation

It was noted that a patient who was sitting up (watching television) andreceiving a cold CVS treatment reported perceiving a different effectthan perceived in prior sessions. Upon reclining to about 45 degrees,she did receive the earlier effect.

The “standard” angle of recline for diagnostic CVS is about 60 degrees(or equivalently 30 degrees above horizontal). The reason for thispositioning is that the “horizontal” SCC is tilted up by about 30degrees (higher on rostal side) (More recent x-ray measurements put theangle at closer to 20+/−7 degrees.) The intent with diagnostic CVS is toreorient the horizontal SCC so that it is substantially vertical, thusmaximizing the effect of the convective flow set up by calorics.

Hence, if the subject is reclined to about 20 degrees above horizontal(and supine), then a cold stimulus leads to inhibition or a phasic rateless than the tonic rate. For a warm stimulus, this situation isreversed (phasic rate increases above tonic).

Further, cold simulation tends to activate principally the contralateralbrain structures whereas hot leads to principally ipsilateralactivation. For example, in V. Marcelli et al. (EUR. J. RADIOL.70(2):312-6 (2009)), the authors did a left ear, cold stimulation bywater irrigation and saw right-side activation in the brainstem,cerebellum, etc. The patient was presumably nearly reclined in the MRImagnet.

Empirical tests and modeling indicate that approximately 20 degreesCentigrade absolute cooling (17 degrees Centigrade below bodytemperature) is the lower limit beyond which the cupula is maximallydeformed and therefore the phasic rate change is maximal. On the warmingside, more than about 7 degrees Centigrade or so above body temperaturebecomes uncomfortable. This level of temperature heating within the earcanal will not lead to maximal deformation of the cupula. Therefore,there is an asymmetry in terms of ability to span the full frequencyspectrum of phasic firing rates. However, the increase in the phasicfiring rate is not constrained in the manner of a decrease—that is, thephasic firing rate can only approach zero, relative to the tonic rate ofroughly 100 Hz, whereas the phasic rate can exceed 200 Hz.

Since inverting the patient changes the sign of theinhibitory/excitatory motion of the cupula, the following can be seen:Using a cold stimulus, of 20 degrees Centigrade absolute, but now orientthe patient so that his head is tilted forward by from 75 to 20 degreesfrom the vertical position. This will invert the horizontal SCC relativeto the image above and now the cold stimulus will result in anexcitatory increase in the phasic firing rate. For clarity, tilting thehead forward by 20 degrees makes the horizontal SCC substantiallyhorizontal. Tilting beyond that now starts to invert it so that at 110degrees (tilted forward), the horizontal SCC will be in a verticalorientation, but now 180 degrees flipped from what is used inconventional diagnostic CVS. So, the “general rule” for treatment ofhaving the patient reclined by 45-90 degrees can be expanded to include“tilted forward” by 75-120 degrees.

Thus a protocol is seen where, using only cold stimulus, one can coverthe entire range of phasic firing rates simply by reorienting thepatient at the appropriate points during the time course of treatment.

Note that this type of inversion should also lead to an inversion in theside of the brain that is primarily activated. Specifically, if coldstimulation leads to principally contralateral activation in the“rightside up” orientation, then it should lead to principallyipsilateral activation in the “upside down” orientation.

Example 12 Thermal Modeling of Caloric Vestibular Stimulation

Equation (4) of Proctor et al. (ACTA OTOLARYNGOL. 79:425-435 (1975)) canbe extended for an arbitrary sequence of heating and/or cooling steps.Equation (4) is a fairly simple usage of the 1-dimensional diffusionequation. Therefore, the model is not exact. The temperature differenceacross the horizontal canal (i.e., the thermal driving gradient) isapproximated:

$\begin{matrix}{{{\Delta\; T} = {{\frac{A_{1}}{\sqrt{t}}{\mathbb{e}}^{\frac{- B}{t}}} + {\frac{A_{2}}{\sqrt{t - t_{1}}}{\mathbb{e}}^{\frac{- B}{({t - t_{1}})}}} + \ldots + {\frac{A_{n}}{\sqrt{t - t_{n}}}{\mathbb{e}}^{\frac{- B}{({t - t_{n}})}}}}}{{{where}\text{:}\mspace{40mu} A_{n}} = {{\frac{- {LT}_{n}}{\sqrt{\pi\; a}}\mspace{34mu}{and}\mspace{45mu} B} = \frac{x^{2}}{4\; a}}}} & (1)\end{matrix}$

L=distance across horizontal canal (mm); default=6

T_(n)=difference between applied temperature and previous temperature(degrees Centigrade)

a=“thermal diffusivity” of temporal bone (mm2/sec); this may vary inpatients, but compact bone paths will dominate the thermal. Theliterature lists values from 0.14-0.25, but this is based on the onsetof nystagmus as the “stimulation time.” Marcelli et al. showed a muchfaster, actual brainstem activation time after CVS, which did not relateto the onset of nystagmus. Literature estimates for the thermaldiffusivity of hard bone range from 0.45-0.55 to 1.6. A value of 0.5 isassumed here, based on x-rays of the compact, wet bone in the region ofinterest.

x=the effective thermal distance (mm) between external ear canal and theedge of horizontal semicircular canal; default=7.5 mm

ΔT=the temperature difference across the semicircular canal (degreesCentigrade); distal minus proximal temperature.

t_(n)=time at which new stimulus starts.

Default values for the constants are listed next to the definitions. CVSapplication times that are short compared to the response time of thepatient may not be very different from a longer pulse at a lowertemperature due to thermal smoothing effects. Literature reports of themaximum phasic firing rate are about 100 Hz. That is, +/−100 Hz awayfrom the tonic firing rate, which is on the order of 100 Hz. The maximumdeformation of the cupula at its center is, correspondingly, about 77microns. Thermal gradients that imply a deformation greater than thisvalue would tend to lead to saturation of the phasic firing rate. At theother end of the scale, the minimum detectable volume change in the SCCis on the order of 25 picoliters and this corresponds to a change in thephasic rate of roughly 0.5 Hz. This indicates a minimum temperaturegradient across the SCC of ˜0.02 degrees Centigrade. The obviousrequirement is that the body's homeostatic temperature regulation mustensure a constant temperature across the 6 mm wide canal to a value onthat order.

Another simplification used in the model was to ignore the temperaturedependence of the bulk coefficient of thermal expansion of water (withthe simplifying assumption that endolymph has roughly the thermalproperties of water). This assumption will lead to an apparentsaturation of the phasic firing rate at higher temperature (roughly 27degrees Centigrade) than will actually occur. Below body temperature,the phasic rate may not saturate until the lower 20's.

The volume of the horizontal SCC is estimated to be: 3.2E-3 cc. Thechange in volume due to a temperature difference ΔT is:3.8E-4*3.2E-3*ΔT=1.22E-6 ΔT.

The volume of the “lens” of the cupula when deformed to its maximal(saturation of the phasic firing rate) extent is roughly: 4.4E-6 ccTherefore, the change in the phasic rate: Δf=27.7*ΔT in Hz.

The relationship between the applied thermal waveform and the phasicfiring rate of the afferents of the vestibular branch of the 8th cranialnerve can thus be modeled for a square waveform stimulus (such as inExample 1 above), and for a time-varying, saw tooth, waveform stimulus(such as in Example 2 above).

It was noted that there is little distortion of the time-varyingwaveform of, as compared to the square waveform, because the body cantrack the more gradual temperature changes.

There is a tendency for the values to skew a small amount vertically(e.g., the temperature delta goes slightly above body temp at points).This effect appears to be non-physical and is simply a limit of theapproximate model employed. The same appears true of the firing rategoing positive.

The “tips” of the sawtooth waveforms appear to exceed the maximum changein phasic firing rate of 100 Hz (this is seen in the square wave aswell). This may be because the coefficient of thermal expansion of theendolymph changes with temperature and was not corrected in the modelabove. This would result in an overestimate of the firing rate for agiven temperature in the plot. Therefore, the firing rate may not, infact, saturate (i.e., will stay below a delta of 100 HZ) at 20 C. Theloss of a sense of improvement reported in Example 3 above fortemperatures below about 17 to 20 degrees Centigrade may be due to thecupula of the vestibular canal “pegging” (achieving its maximal physicaldistortion) and the firing rate saturating.

Example 13 Treatment of Chronic Migraines and Refractory Depression

A female subject was a headache sufferer with a 10-year history ofdebilitating, chronic migraines, the last five being refractory. She hadfailed all pharmaceutical interventions. The patient underwent anoccipital nerve stimulator implant for headaches, with goodsymptom-management for approximately one year, at which point the devicewas no longer effective. Co-morbid with her migraine headaches wasdepression, which was only partially responsive to pharmaceuticalmanagement. Subject was placed on disability from her employment.

The subject was treated using a five-day therapy paradigm consisting ofdaily treatments comprising a square waveform pattern of cooling to 20degrees Centigrade, at a frequency of one cycle every ten minutes, for atotal duration of ten minutes while the patient was in a reclinedposition of thirty degrees above horizontal. Video images of the subjectwere captured before, during and after each treatment session and wereused to assess the effectiveness of the treatment (e.g., by assessingthe patient's mood).

For all active, in-process migraine episodes, within 5-15 minutes aftercompletion of a treatment, subject experienced pain attenuation. Chronicheadache indication was alleviated on the 4^(th) day of treatment, withconcurrent progressive improvement in her mood over the course of thefive days. The treatment course peaked at day 5. The subject becamepain-free, with complete resolution of mood symptoms. She remainedpain-free for 63 days after the therapy was completed, at which time hermigraine headaches began to recur, but without return of clinical moodsymptoms.

The five-day therapy paradigm was repeated. The subject responded morequickly to this second longitudinal therapy, with her chronic headachesdisappearing on the 3^(rd) day of treatment. She remained pain-free forfive weeks.

Later, the patient was treated with a sawtooth waveform (lowertemperature of 20 degrees Centigrade) employing a daily treatmentduration of 10 minutes. By the end of the treatment week, the patientwas pain free (using a 0-3 pain scale where 3 is severe, 2 is moderate,1 is mild, and zero is no pain). Charted pain scores (not shown) showedimprovement after treatment. All CVS treatments were to the right earusing cold stimulation. Additionally, after each treatment week, thepatient stayed pain free for times varying from 2-9 weeks. The patientadditionally reported feelings of high energy and resolution ofco-morbid depression.

Example 14 Treatment-Associated Dizziness in Migraine Patient

The same subject described in example 8 had right ear CVS treatmentusing a heating, to approximately 42-43 degrees, sawtooth waveform for10 minutes, with a contiguous repeat for an additional 10 minutes. Thetreatment was effective in resolving her acute migraine pain.Additionally, the treatment had a soporific effect but also causedslight dizziness. The subject did not note the feeling of dizziness inexample 8 using cold stimulation.

Example 15 Treatment of Cluster Headache and Treatment-AssociatedDizziness

The same subject described in example 1 underwent the same CVS treatmentdescribed in example 14. He too reported a feeling of slight dizzinessthat was not apparent during cold CVS stimulation.

Example 16 Vestibular Migraine Treatment in Female Patient

A female subject in her late 30's had a history of migraine withassociated vertigo (vestibular migraine). The subject has a history ofvestibular dysfunction and slight co-morbid depression. The subject wastreated on a near daily basis, between 20-40 minutes per day, with coldstimulation (down to 20 degrees Centigrade) CVS before switching to warmCVS, with a maximum temperature of 48 degrees Centigrade. All CVStreatments used a sawtooth pattern with left-ear stimulation due to moresevere vestibular dysfunction in the right ear. This subject did notnote dizziness as a side effect of the warm CVS treatment, suggestingthat her vestibular system, due to dysfunction, is more immune to CVS(and thus she must treat more aggressively to gain benefit). A parent ofthe subject commented on a change in the subject's speech and “spirit”during phone conversations while using cold CVS. The switch to warm CVSresulted in additional mood and motivational elements. Colleaguescommented on enhanced interpersonal interactions and an increased senseof confidence. The subject stated: “for the last couple of year I'vefelt as if my brain has burnt out, it feels so much better since thewarm treatments.”

Example 17 Vestibular Migraine Treatment in Male Patient

A male in his 40's developed sudden onset migraine with vestibulardysfunction that led to effective disability and inability to go towork. The subject was not helped by medications and sought the advice ofmultiple physicians at two prominent academic research hospitals. Thesubject was treated on a near daily basis for 10-20 minutes a day withcold CVS (down to 20 degrees Centigrade) CVS before switching to warmCVS, with a maximum temperature of 42 degrees Centigrade. The subject,like the subject in example 16, did not experience dizziness with theintroduction of warm CVS treatments, possibly associated with thevestibular dysfunction accompanying his migraines. CVS treatments aresoporific for this patient. The subject's wife notes a pronounced changesince CVS treatments were started. Whereas prior to CVS treatment thesubject was loath to get out of bed, since CVS treatment the subject hasreturned to part-time work with his employer.

Example 18 Treatment of Diabetic Patient with Warm Sawtooth Stimulation

The same subject described in example 9 switched from cold CVS to warmCVS for the control of his type II diabetes. He treated with a sawtoothwaveform that oscillated between 34 and 43 degrees Centigrade. Theaverage heating slew rate was typically above 40 degrees Centigrade/minand the average cooling slew rate was typically greater than 10 degreesCentigrade/min. Since commencing CVS therapy, the subject has stoppedtaking medications, which were previously necessary to maintain serumglucose near a normal range. At the time of diagnosis, the subject's A1cvalue was 9.8. At the time shown at the end of the chart below, thatvalue was reduced to 5.6 (again, with no medications). A1c is viewed asa better long-term marker of diabetes control than serum glucose (itdoesn't fluctuate). The normal range is about 4-6. For diabetics, therecommendation is that anything below 7 is a good target. A record ofthe subject's serum glucose readings (not shown) indicated possibleadditional improvement realized with the switch from cold to warm CVS interms of reduced variability. The subject also had a gingival abscessduring the period shown and such infections can lead to oxidative stressand impaired glucose control (see generally J. Southerland et al.,Diabetes and Periodontal Infection: Making the Connection, ClinicalDiabetes 23, 171-178 (2005)). The infection did not disrupt thesubject's glucose maintenance.

Glucose readings taken at 7 AM and 10 PM; CVS treatment in evening.Treatment 1: 34 to 17 degree C. sawtooth waveform, 20 minute duration.Treatment 2: 34 to 43 degree C. sawtooth waveform, two 20 minutetreatment per day. Glucose levels are more controlled with treatment 2.No other diabetes medications were in use during the testing period. Thesubject reported that the warm sawtooth CVS differed slightly from thecold sawtooth CVS in that it appeared to have increased potency as notedby the feeling of increased dizziness and mild nausea, which appearconsistently with each treatment. Glucose levels tend to drop 10-30points approximately 60 minutes or more after the treatment. The subjectreported that combining exercise in proximity to the TNM therapyappeared to cause a glucose decrease of 30 to 50 points.

Example 19 Treatment of PTSD Patient

A male in his mid 60's was wounded three times as a Medic in Vietnam andhad a history of post-traumatic stress disorder. His manner is describedas introverted and his mood depressive. After the commencement of coldCVS treatments, the subject's wife reported that he started becomingmore extroverted. She reported that “she did not know who this personwas speaking to her this morning”; that he was planning getting togetherwith friends; that usually he would only do this if forced; that heexpressed interest in going to Africa for a photo safari; that shestarted thinking “where is my husband?” After a second treatment, thesubject reported continuous sleep throughout the night (usually he wouldusually wake up 3-4 times). He commented that “insomniacs should usethis.” The subject reported feeling energized. The subject was usuallyunable to recall dreams, but awoke with visual flashback of events inVietnam, not unpleasant just old visual memories, and returned to sleep.The subject traditionally avoided driving but now is driving withsubstantially less hesitation. The subject is a serious amateur painterand both the subject and his spouse report significant positivedevelopments in his painting style and productivity since commencementof his CVS. Upon interruption of CVS therapy, PTSD symptoms graduallyreturned almost to baseline one week after CVS stopped.

Example 20 Treatment of Diabetes in a PTSD Patient

The patient of example 19 has type II diabetes. After the commencementof CVS therapy he became much more responsive to oral hypoglycemics, hashad to cut dose significantly (data not shown).

Example 21 Alternative Waveforms in Treatment of Diabetes and ClusterHeadaches

The patient described in example 18 above was administered threedifferent waveform CVS stimuli, as follows:

-   -   A: Cooling, by approximately 22-23 degrees, with a spike        waveform for 10 minutes with a contiguous repeat for an        additional 10 minutes.    -   B: Heating, to approximately 42-43 degrees, with a spike        waveform for 10 with a contiguous repeat for an additional 10        minutes.    -   C: Cooling, to approximately 22-23 degrees, with a spike        waveform for 10 minutes as illustrated in connection with A        above, followed immediately by heating, to approximately 42-43        degrees, with a spike waveform for 10 minutes as illustrated in        connection with “B” above.        The treatments seemed to have a bimodal pattern of efficacy        based upon cooling or heat cycles. Both modes seem to induce a        sense of motion and mild nausea associated with enhanced        therapeutic efficacy for the treatment of cluster headaches and        the stabilization of type II diabetes in this subject. Pattern A        appeared to be the most efficacious. Increasing cycle times to        thirty minutes does not appear to confer an additional benefit.

Example 22 Induction of Prolonged Nystagmus by Waveform CVS

Nystagmus is the name given to involuntary eye movements enabled by theso-called vestibulo-ocular reflex (VOR). CVS provides an artificialmeans to activate the VOR. By tilting the head (˜20 degrees above thehorizontal), the horizontal SCC is placed in a vertical orientation.Creating a differential temperature across this canal results inconvection currents that act to displace the cupula. Warm CVS leads tocupular displacement such that the phasic firing rate increases whereascold CVS leads to a decrease in the firing rate. Further, warm CVSresults in nystagmus that is manifested by a rapid movement of the eyestowards the simulated ear. Cold CVS results in the rapid phase ofnystamus away from the stimulated ear. Therefore, by noting theexistence and the direction of nystagmus, one may determine that the VORis being activated and whether the phasic firing rate is greater than orless than the tonic firing rate.

The use of continuous CVS irrigation or stimulation at a constanttemperature will induce nystagmus, but after a time on the order of 2-3minutes (e.g., Bock et al., Vestibular adaptation to long-term stimuli,BIOL. CYBERNETICS 33:77-79 (1979)), the cupula will adapt to its new,displaced position and the phasic firing rate will return to the tonicrate. Thus nystagmus will effectively cease and the vestibular nerveafferents will no longer be stimulated.

It is an aspect of the current invention that the use of time-varyingthermal waveforms enables the persistent stimulation of the vestibularnerve afferents, beyond the time period at which adaptation to aconstant thermal stimulus occurs. In this example, the present inventionhas been used to generate nystagmus over a 12 minute period as measuredby videonystagmography and by electronystagmography. A sawtooth coolingwaveform going between temperatures of 34 to 20 degrees Centigrade wasapplied to the right ear of a subject who was reclined such that hishead was ˜20 degrees above the horizontal. Electronystagmography wasused to measure the movement of his eyes, and demonstrated the existenceof nystagmus both early in a 12 minute period and near the end of the 12minute period (data not shown).

Example 23 Effect of CVS on Regional Cerebral Blood Flow (rCBF)

The purpose of this Example is to find a robust marker of successful CVSinduction of relevance to neurological treatments. The study is beingperformed on rats using a modified version of a dual ear CVS unit.Specifically, ear bars that are connected to TEC's are placed in the earcanals of rats that have been anesthetized. The device has dual earstimulation capability.

Methods and Results:

Single ear CVS: Rat #9 received a sawtooth waveform in the right earthat oscillated between 36 and 14 degrees Centigrade for 60 minutes (notshown). The rat was anesthetized with isoflurane. It should be notedthat anesthesia may lessen the effects of CVS to a degree. The rat wasoriented horizontally, which places the horizontal semicircular canal inthe vestibular bodies at a roughly 30 degree tilt upwards on theanterior side. After the end of the 60 minute right ear stimulation, thesame caloric waveform was then applied to the left ear. The response ofthe regional cerebral blood flow was measured on the right parietalregion of the skull via a laser Doppler probe affixed to the skull.Roughly 30 minutes after the start of right ear CVS, the oscillation inblood flow became pronounced. The period of the sawtooth temperaturewaveform is 1.9 minutes. As observed (using nearest neighbor averaging),the period of the modulation in blood flow is longer, by about 30seconds on average (data not shown). This suggests that the drivingforce (the CVS) leads to modulation of the blood flow via a mechanismthat stays in a non-equilibrium state. That is, the rat's response doesnot simply match the period of the CVS waveform and is instead adaptingto it dynamically. At the end of right ear CVS, the oscillations stop.Roughly 35-40 minutes after the start of left ear CVS, clearoscillations once again appear, though diminished in amplitude relativeto right ear stimulation. This is presumably due to the fact that leftear stimulation has a weaker effect on blood flow in the right portionof the brain. Serrador et al. (BMC Neuroscience 10, 119 (2009)) notethat “connections have been found between the vestibular nuclei and thefastigial nucleus . . . followed by vasodilatory connections to thecerebral vessels.”

Control Run:

The Vestibular stimulation device was placed on the rat, but was notactivated. No oscillations in rCBF were seen (the downward drift in theflow data is due to a slight shift in the baseline of the probe).

Dual Ear, Same Waveform:

Rat #12 had CVS delivered to both right and left ears simultaneously(not shown). The waveforms were not tied in phase and tended to becomeout of phase during the bulk of the 60 minute treatment period. Nomodulations in rCBF were manifested (data not shown).

The dual ear stimulation data suggest that the application of the samewaveform to both ears simultaneously acted to cancel out any netmodulatory effect on rCBF. However, it is still the case that the samestimulation was given to the vestibular nuclei as when only single earCVS was used. Nystagmus, would also not appear if the same CVSstimulation were applied to both ears since the phenomenon, mediated bythe vestibulo-ocular reflex (VOR), requires a differential input to thetwo horizontal SCC's. Thus the absence of rCBF modulation does not meanthat the fastigial nuclei (both nuclei for dual ear CVS) are not beingstimulated. Rather, their combined activation yields no net effect onrCBF. Since modulation of rCBF is not a necessary aspect of CVS inducedneuroprotection (it is a marker of CVS induction), CVS therapy mayactually be as or more effective with dual ear stimulation.

Dual Ear, Different Waveforms:

Run 17 simultaneously applied a 34 to 44 C sawtooth waveform to theright ear (period of ˜40 seconds) and a 34 to 13 C sawtooth (period ˜1.7min.) to the left ear (not shown). In this case, flow modulations wereseen and they persisted well past the end of the CVS treatment period(not shown). In this case the flow effect, with different temperaturesapplied, not only was present but continued to oscillate after the endof the active CVS treatment.

Discussion:

The vestibular systems of all mammals act in the same way. Therefore,the results of the rat study discussed above have implications for humanCVS therapy as well. The conclusion from the study is that the mostlikely cause of the modulation seen in rCBF is that CVS does stimulatethe fastigial nucleus in the cerebellum.

Example 24 EEG in Rats as a Metric of CVS Efficacy

EEG is useful in identifying cortical activation associated with CVS.Therefore, EEG is useful as a non-invasive means to titrate CVS therapy.This report summarizes EEG data acquired in a rat study.

Methods and Results:

The report on regional cerebral blood flow changes in a rat duringvarious CVS treatments has been generated. In this summary, EEGelectrodes were placed in the scalp of the rat, differential pairs beingapplied on either side of the midline of the skull. (data not shown).

Discussion:

The activity observed in the theta band was markedly different betweenthe 3 states. For the low flow state, activity was depressed. The highflow peaks were shifted to lower frequencies as compared to the baseline(pre-CVS). In the 0-40 Hz plot, the high and low flow peaks in thelow-30 Hz range overlap whereas the baseline peak is shifted (this islikely due to a difference in somatosensory perception during CVS versuspre-CVS). The sensitivity of EEG spectra to the details of CVS deliverysuggest that EEG is an effective tool for evaluating the differencebetween CVS waveforms and for titrating them.

Example 25 Heart Rate Variability (HRV) as a Metric of CVS Efficacy

Heart rate variability seems to be a significant marker of health andsystems for measuring it non-invasively are becoming common. This reportdescribes the use of the ithlete, a commercial HRV measurementinstrument that runs as an smartphone software program, or “app.”

Methods and Results:

The subject is a 40-45 year old male diagnosed with seasonal clusterheadaches. The device used to measure HRV is the ithlete (HRV Fit Ltd.,Hants UK)) which uses an iPhone as the recording/readout device and achest strap with sensors that monitor heart rate. The HRV parameter iscalculated via a proprietary algorithm that takes the raw heart ratedata as input. Note: of course there are many devices that will measureHRV and the ithlete was chosen only as a low cost and convenient system.Proper HRV is used as a metric of proper cardiac health (good healthimplies adequately high HRV; e.g., Malik, Heart rate variability:standards of measurement, physiological interpretation, and clinicaluse, EUR. HEART J. 17:354 (1996)). For example, Gujjar et al. havelinked HRV and outcomes after acute severe stroke (“Heart ratevariability and outcome in acute severe stroke,” Neurocritical Care,vol. 1, pg. 347, 2004).

The CVS treatment was a 42 degrees Centigrade sawtooth wave applied tothe left ear and a 17 degrees Centigrade sawtooth applied to the rightear. The treatment lasted for 10 minutes. HRV data were recordedimmediately after the end of the treatment. HRV is a dimensionlessmeasure. During the October 24^(th) test, average HRV dropped by 30% andon October 28^(th) by 27% (data not shown).

Discussion:

HRV is proposed as a marker of effective CVS induction and could thus beused as a tool for titrating CVS dosing. Pathological conditions (suchas cluster headaches discussed here) can lead to elevated HRV levels.Other pathological conditions, e.g., cardiac insufficiencies, are oftenassociated with abnormally low HRV values (for that individual).

Example 26 Treatment of Fibromyalgia

A subject (also female, age 50-55) was diagnosed with fibromyalgia 3years ago. Multiple allopathic and homeopathic interventions provided nosubstantive relief. The subject has co-morbid migraine headaches.

Methods and Results:

The subject underwent CVS treatment in the right ear, with a 17 degreeC. sawtooth waveform.

From September 13-19 the subject stopped CVS treatment due tosignificant pain and inability to function. On September 20 the subjectbegan treatments twice per day, sometimes using a 3^(rd) daily treatmentusing the CVS parameters listed above. She realized an improvement inboth migraine pain and pain from fibromyalgia. In the September 28-30timeframe thunderstorms seemed to trigger additional migraine pain, butthis abated over the following days until her pain level was barelynoticeable.

The subject commented upon starting twice-a-day treatments: “I′m writingto report excellent results using 2 treatments. Last night I tried 2consecutive treatments, and I felt great! Like I′d been to a spa and hada relaxing massage and soak in the hot tub.”

The subject reported on September 26^(th): “This weekend I was able towork with [husband] getting 14 new bushes in the yard and picking outnew paint at Lowe's to repaint the shutters on the house. I′m so veryhopeful and happy. Gardening is a shared passion for us, and the firsttwo years here, I wasn't able to even water the plants, so the ones leftare real survivors! I feel like you are giving me my life back, andgiving [husband] his wife back”

When the subject's spouse was asked if the Vestibular stimulation devicewas truly helpful he responded: “Nothing in the last 3 years had helpedbefore this.”

After October 6, the unit was retrieved. The subject has since returnedto baseline.

Example 27 Treatment of Peripheral Neuropathy

A female subject underwent spinal surgery and sustained damage to thespinal cord. Thereafter she has had intractable peripheral neuropathy(foot pain) over a roughly 4 month period that had not responded toanalgesics. The subject has obtained relief using CVS, with the extentand duration of relief depending on the device used and the waveformdetails.

Methods and Results:

The subject underwent CVS treatment with the following chronology:

-   -   1. Dual ear CVS unit: L-ear, sawtooth, 34 to 20 degrees        Centigrade; R-ear, sawtooth, 34 to 42 degrees Centigrade, 10        min. therapy. The treatment made her very sleepy (deep sleep for        20 min). Within 30 minutes, she was pain free and stayed so for        3 days, which was extraordinary for her.    -   2. Single (right) ear CVS unit, sawtooth, 34 to 17 degrees        Centigrade, 10 min therapy. She realized about a 50% reduction        in pain level that lasted around 2 hours.    -   3. Single (right) ear CVS unit, long (single rise) square wave,        34 to 48 degrees Centigrade, 10 min. She finds that the single        ear, warm treatment is better than single ear, cold treatment.        She must use the device several times a day to achieve pain        relief.    -   4. Dual ear CVS unit, L-ear 17 degrees Centigrade square wave,        R-ear 44 degrees Centigrade sawtooth, 10 min Deep sleep for 45        min (at 5 PM). Foot pain ceased.

Discussion:

The subject received extended (multiple day) pain relief from one 10 minsession using dual ear CVS. Single ear CVS, using a sawtooth waveform(slower slew rate) and an early device (basically a single cold/warmsquare wave), led to partial pain reduction for a time limited to hours.Therefore, the dual ear CVS treatment was superior to single ear forpain reduction. This subject and another have stated that the mixedwaveform, dual ear (e.g., example 4) results in more significantsubjective sensations (deep relaxation/sleep for this subject, increasednausea for the other). It is unclear with this single case if the mixedwaveform treatment leads to increased pain reduction efficacy (both dualear treatments were significant).

Example 28 Single Ear Treatment of Episodic Migraine

This Example evalutes the feasibility of using a portable CVS unit in ahome setting over a month or more. The hypothesis was that daily CVStreatment would reduce the overall pain level and frequency ofheadaches.

Methods and Results:

The subject is a 50-55 year old female with a history of 6-8 migraineheadache days per month (a month is taken as 28 days when reporting onmigraine frequency). The subject used a right-ear Vestibular stimulationdevice and a sawtooth waveform that went from 34 degrees Centigrade to17 degrees Centigrade with a period of roughly 1.7 minutes. The durationof the treatment was 10 minutes per session (daily sessions, moving toevery other day after about 2 weeks of treatment). The average slew ratefor heating was 40 degrees Centigrade/minute and the average slew ratefor cooling was 14 degrees Centigrade/minute.

The subject experienced a decrease in pain over the first week oftherapy. (pain score data not shown). In the 40 days past the one weektransitionary period, the subject had only one migraine headache (again,to qualify as a migraine it must be at a pain level of 6 or more on ascale of zero to ten and last for 4 hours or more). The one headacheoccurred during unusual stress associated with a transatlantic trip anddisruption of work schedule upon her return. The subject also noted asubjective improvement in co-morbid depression over the treatmentperiod.

Example 29 Titration of CVS Therapy for Type II Diabetes

The intent of this report is to show experimental evidence of thecontrol of glucose levels by adjusting the frequency with which CVS isused in a subject with type II diabetes.

Methods and Results:

The subject is a 40-45 year old male diagnosed with type II diabeteswithin the last two years. As reported earlier, the subject has beenable to forego the use of medications to control serum glucose levels,using CVS therapy instead. Recently, the subject has started using dualear CVS, with a warm time-varying waveform applied to one ear and a coldtime-varying waveform applied to the other. The dual ear therapy reducedthe frequency with which the subject needed to use CVS in order tocontrol serum glucose levels (data not shown). Dual ear CVS was usedwith a 17 degrees Centigrade square wave for the right ear and a 42degrees Centigrade sawtooth on the left ear. Each point in the graphrepresents a daily measurement (consistent time during each day). Thered lines show when CVS was used. As the glucose levels were tracked,they would tend to move up in between CVS treatments, thus signalingwhen another treatment should be applied. This feedback method should beable to be extended to other patients, using their specific glucoselevels to titrate frequency and intensity of CVS treatments. Thissubject remains off any other medications to control glucose levels.

Discussion:

This is an update report to supplement accounts from this subjectalready included in the Examples above, and further shows that serumglucose is a useful metric for CVS titration.

Example 30 CVS Intensity for Different Waveforms

As the CVS treatment device has evolved, we have moved from single todual ear stimulation and have increased the slew rate to allow waveformsto be played out at a higher frequency. This report lists subjectivemetrics that can be used to assess the strength of CVS stimulation for agiven subject.

Methods and Results:

The subject is a 40-45 year old male using CVS therapy chronically fortype II diabetes and seasonal cluster headaches. He ranks the level ofintensity of the CVS experience as follows:

-   -   1. single ear:        -   daily treatments were required to control cluster headaches            and serum glucose levels        -   typical treatment is a cold sawtooth wave going between 34            and 17 degrees Centigrade    -   2. dual ear, same waveform shape, warm and cold:        -   only 1-3 treatments per week are needed to control cluster            headaches and serum glucose        -   typical waveform is a sawtooth going from 34 to 42-44            degrees Centigrade in one ear and 34 to 17 degrees            Centigrade in the other ear.        -   Not much subjective difference compared with single ear            during treatment            -   More pronounced dizziness upon standing            -   Nausea more persistent            -   Faster, more complete responses for increased pain level            -   Blurred vision for 3-5 minutes (possibly nystagmus)    -   3. dual ear, different waveform shape, warm and cold:        -   only 1-3 treatments per week are needed to control cluster            headaches and serum glucose        -   typical waveform is a sawtooth going from 34 to 42-44            degrees Centigrade in one ear and a square wave in the other            ear going from 34 to 17-20 degrees Centigrade.        -   most potent of all types tried in terms of pain mitigation            and positive mood effects (side effects do not outweigh            additional benefits)            -   sleep inducing            -   nausea while in horizontal position            -   significant nausea and brief period of poor postural                control upon standing            -   persistent feeling of head fullness

Discussion:

The most significant metrics for CVS therapy for pain patients is itseffects on pain level and relative side effects. This report recountsobservations by one subject that can serve as a paradigm for how otherpatients can be assessed in the clinic. The right titration will involvean on-going assessment of effects on symptoms (e.g., pain) andminimization of unwanted, lasting side effects (for clarity, the sideeffects reported above are transient). There are tradeoffs that patientscan make between efficacy with more intense side effects balancedagainst less frequent need to treat.

The following parameters can be varied in a dual ear system:

-   -   1. temperature (magnitude and sign with respect to body        temperature);    -   2. waveform shape;    -   3. frequency of waveform(s); if they are different frequencies,        they could be commensurate and beat frequencies could be        established;    -   4. relative phase of waveforms (e.g., in phase or some degree of        being out of phase if they have the same frequency); and    -   5. variable frequency during the course of a treatment (each        side).        The Vestibular stimulation device can be programmed, in        principal, to play out a different combination every day, thus        frustrating any tendency of the VS of the patient to adapt to a        given therapeutic waveform. This is a principal advantage of        dual ear over single ear CVS.

Example 31 Treatment of Sleep Disorders/Insomnia with CVS

A common report from users of the Vestibular stimulation device is thatthey have beneficial effects in terms of sleeping soundly. It is known(e.g., Horii et al., J. NEUROPHYSIOL. 70:1822 (1993)) that CVS doesactivate the hypothalamus. The hypothalamus in turn controls thesleep/wake cycle in mammals.

Methods and Results:

The reports of the soporific effects of CVS with subjects is variableand subjective. Listing the claims by subjects in order of frequency:

-   -   1. a relaxed feeling right after the completion of a CVS        treatment;    -   2. report of having an exceptionally complete sleep cycle on the        night following a CVS treatment; and    -   3. a very powerful soporific effect that resulted in the subject        falling asleep during a 10-20 minute CVS treatment and staying        asleep for up to several hours.        Examples of Each of the Observations Listed Above:    -   1. A small pilot clinical trial was performed at a private        headache clinic on patients who were being treated for migraine        headache. The CVS waveform used was a sawtooth, right ear only,        with the temperature oscillating between 34 and 17 degrees        Centigrade. None of the subjects fell asleep during the 10        minute CVS treatment, but commonly reported being relaxed in a        way that was greater than what they would feel when lying down,        in a similar position, for the same amount of time.    -   2. A male, age 50-55 acting as a normal test subject used single        ear (right) CVS, sawtooth waveform oscillating between 34 and 17        degrees Centigrade. He reported pleasant drowsiness after the 10        minute therapy session and then reported that he'd slept        exceptionally soundly that night.    -   3. A subject using CVS for foot pain (see previous Example on        this subject) used a dual ear Vestibular stimulation device:        L-ear, sawtooth, 34 to 20 degrees Centigrade; R-ear, sawtooth,        34 to 42 degrees Centigrade, 10 min. therapy. The treatment made        her very sleepy (deep sleep for 20 min). Then again: dual ear,        L-ear 17 degrees Centigrade square wave, R-ear 44 degrees        Centigrade sawtooth, 10 min. Deep sleep for 45 min (at 5 PM) and        had to be awakened.        In all cases, subjects reported restful sleep versus “forced”        sleep and they reported no ill side effects.

Example 32 Single Ear CVS Treatment of Pediatric Epilepsy

The intent with this study was to evaluate using the Gen 2.0 CVS unit(left ear only, same earpiece but different (less powerful) TEC(thermoelectric cooler or Peltier cooler) than will be used in Gen 3device) in a single session to observe any effects on spike activity inepileptic patients as monitored by EEG.

Methods and Results:

The subjects were treated with a sawtooth waveform that went from 34degrees Centigrade to 17 degrees Centigrade (left ear only). Note thatthe actual temperature profile was not the same for all patients. Forpatient 3, the average slew rate on heating was around 14-15 degreesCentigrade/min and the cooling rate dropped from about 5.8 degreesCentigrade/min to 4.5 degrees Centigrade/min (not shown). It can be seenthat more time was required to in the second “dip” to get to 17 degreesCentigrade. This is due to insufficient power in the Gen 2.0 Vestibularstimulation device.

For patient 4, the inadequate power of the unit is even more apparent.The average heating slew rate was about the same as with patient 3, butthe cooling rate started at 4.2 degrees Centigrade/min and dropped to3.6/min (not shown). The device failed to reach the 17 degreesCentigrade target temperature.

The spike rate was measured by continuous EEG before CVS treatment andafter CVS treatment (data not shown). The decrease in spike rate lastedfrom 1-2 hours for each of the four patients. The reduction in spikingranges from 21-32%.

Discussion:

despite the underperformance of the Gen 2.0 model, primarily caused byan older, less powerful TEC and the lack of a cooling fan on the heatsink, demonstrable effects were seen in all 4 patients in terms of areduction in spike activity that persisted past the end of the CVStreatment session. At this time, we don't have the ability to try a moreadvanced device (e.g., Gen 2.5) with these patients. A logical coursewould be to treat the patients longitudinally to see if the effects ofCVS could be made more lasting. Despite the challenge of performing CVSon this population (age range from 6-10 years old), it was accomplishedand there were no side effects of the treatment.

The foregoing is illustrative of the present invention, and is not to beconstrued as limiting thereof. The invention is defined by the followingclaims, with equivalents of the claims to be included herein.

That which is claimed:
 1. A vestibular stimulation device comprising: anearpiece; a thermoelectric device (TED) thermally coupled to saidearpiece; and a controller operatively connected to said TED, saidcontroller comprising: a prescription comprising a set of instructionsfor delivering one or more thermal waveforms to at least one of thevestibular system and the nervous system of a patient; and a controlmodule configured to activate said TED to deliver the prescribed thermalwaveform(s), wherein the one or more thermal waveforms are configured tomaintain a vestibular stimulation that is sufficient to alter avestibular phasic firing rate to thereby induce nystagmus over a periodof more than three minutes.
 2. The vestibular stimulation device ofclaim 1, wherein said set of instructions for delivering one or morethermal waveforms to at least one of the vestibular system and thenervous system of a patient is stored in a prescription database.
 3. Thevestibular stimulation device of claim 2, wherein said prescriptiondatabase reside(s) in a device selected from the group consisting of apatient control device, a physician control device, a physician supportdevice and a registry.
 4. The vestibular stimulation device of claim 3,wherein said prescription database resides in a registry that comprisesprescriptions from at least one of one or more physician control devicesand one or more physician support devices.
 5. The vestibular stimulationdevice of claim 2, wherein said waveform database reside(s) in a deviceselected from the group consisting of a patient control device, aphysician control device, a physician support device and a registry. 6.The vestibular stimulation device of claim 5, wherein said waveformdatabase resides in a registry that comprises thermal waveforms from atleast one of one or more physician control devices and one or morephysician support devices.
 7. The vestibular stimulation device of claim2, wherein at least one of said prescription database and said waveformdatabase reside(s) in said controller.
 8. The vestibular stimulationdevice of claim 1, wherein said vestibular stimulation device furthercomprises a sensor operatively connected to said controller, said sensorconfigured to transmit data associated with the temperature of theearpiece to said controller.
 9. The vestibular stimulation device ofclaim 8, wherein said control module is configured to use said dataassociated with the temperature of the earpiece to ensure that theappropriate one or more thermal waveforms are delivered to thevestibular system and the nervous system of said patient.
 10. Thevestibular stimulation device of claim 9, wherein using said dataassociated with the temperature of the earpiece to ensure that theappropriate one or more thermal waveforms are delivered to at least oneof the vestibular system and the nervous system of said patientcomprises adjusting an activation signal used to drive said TEDresponsive to said data associated with the temperature of the earpiece.11. The vestibular stimulation device of claim 10, wherein said sensorrepeatedly transmits data associated with the temperature of theearpiece to said controller and wherein said controller repeatedlyadjusts the activation signal used to drive said TED.
 12. The vestibularstimulation device of claim 8, wherein said controller is configured toshut down if the temperature of the earpiece drops below a lowtemperature threshold or exceeds a high temperature threshold.
 13. Thevestibular stimulation device of claim 12, wherein said low temperaturethreshold is 10 degrees Centigrade.
 14. The vestibular stimulationdevice of claim 12, wherein said high temperature threshold is 50degrees Centigrade.
 15. The vestibular stimulation device of claim 1,wherein said controller further comprises a treatment module configuredto generate one or more prescriptions.
 16. The vestibular stimulationdevice of claim 15, wherein said treatment module is configured togenerate a prescription responsive to receiving user input, wherein saiduser input comprises selection of a thermal waveform from a waveformdatabase.
 17. The vestibular stimulation device of claim 15, whereinsaid treatment module is configured to generate a prescriptionresponsive to receiving user input, wherein said user input comprisesmodification of a thermal waveform selected from a waveform database.18. The vestibular stimulation device of claim 1, wherein saidcontroller further comprises a feedback database configured to storedata associated with the delivery of one or more thermal waveforms tothe vestibular system and for the nervous system of said patient. 19.The vestibular stimulation device of claim 18, wherein said controllercomprises a portable memory device interface and said prescriptiondatabase, and at least one of said waveform database and said feedbackdatabase reside(s) on a portable memory device inserted into theportable memory device interface.
 20. The vestibular stimulation deviceof claim 19, wherein said portable memory device interface comprises anSD memory card interface and said portable memory device comprises an SDmemory card.
 21. The vestibular stimulation device of claim 1, whereinsaid controller is configured such that the patient is prevented from atleast one of modifying and deleting said prescription.
 22. Thevestibular stimulation device of claim 1, wherein said vestibularstimulation device further comprises a heat sink and wherein said TED isthermally coupled between said earpiece and said heat sink.
 23. Thevestibular stimulation device of claim 1, wherein the set ofinstructions for delivering one or more thermal waveforms comprising theprescription includes instructions for providing a plurality ofspaced-apart treatment sessions over a defined period of time.
 24. Thevestibular stimulation device of claim 1, wherein the set ofinstructions for delivering one or more thermal waveforms comprising theprescription includes an expiration time after which the controllerprohibits delivery of the one or more thermal waveforms.
 25. A method ofdelivering one or more thermal waveforms to at least one of thevestibular system and the nervous system of a patient, comprising:generating a prescription comprising a set of instructions fordelivering one or more thermal waveforms to at least one of thevestibular system and the nervous system of said subject; and deliveringthe prescribed thermal waveform(s) to at least one of the vestibularsystem and the nervous system of the patient using a vestibularstimulation device, wherein the prescribed thermal waveforms areconfigured to maintain a vestibular stimulation that is sufficient toalter a vestibular phasic firing rate to thereby induce nystagmus over aperiod of more than three minutes.
 26. The method of claim 25, whereinsaid vestibular stimulation device is a vestibular stimulation deviceaccording to claim
 1. 27. The method of claim 25, wherein saidprescription is generated using said vestibular stimulation device. 28.The method of claim 25, wherein said prescription is generated using aphysician control device.
 29. The method of claim 25, wherein generatinga prescription comprises selecting a thermal waveform from a waveformdatabase.
 30. The method of claim 29, wherein said waveform databaseresides in said vestibular stimulation device.
 31. The method of claim30, wherein said vestibular stimulation device comprises a portablememory device interface and said waveform database resides on a portablememory device inserted into the portable memory device interface. 32.The method of claim 31, wherein said portable memory device interfacecomprises an SD memory card interface and said portable memory devicecomprises an SD memory card.
 33. The method of claim 29, wherein saidwaveform database resides in a device selected from the group consistingof a physician control device, a physician support device and aregistry.
 34. The method of claim 33, wherein said waveform databaseresides in a registry that comprises thermal waveforms from at least oneof one or more physician control devices and one or more physiciansupport devices.
 35. The method of claim 29, wherein said waveformdatabase is periodically updated.
 36. The method of claim 25, whereingenerating a prescription comprises modifying a thermal waveformselected from a waveform database.
 37. The method of claim 25, furthercomprising: monitoring the patient's response to the prescribed thermalwaveform(s); modifying the prescription based upon the patient'sresponse to the prescribed thermal waveform(s); and delivering one ormore thermal waveform(s) to at least one of the vestibular system andthe nervous system of the patient using the vestibular stimulationdevice in accordance with the modified prescription.
 38. The method ofclaim 25, wherein generating a prescription comprising the set ofinstructions for delivering one or more thermal waveforms includesgenerating instructions for providing a plurality of spaced-aparttreatment sessions over a defined period of time.
 39. The method ofclaim 25, wherein generating a prescription comprising the set ofinstructions for delivering one or more thermal waveforms includesgenerating an expiration time, and prohibiting a delivery of the one ormore thermal waveforms after the expiration time.
 40. A vestibularstimulation system comprising: a physician control device configured togenerate a prescription comprising a set of instructions for deliveringone or more thermal waveforms to at least one of the vestibular systemand the nervous system of a patient; and a vestibular stimulation deviceconfigured to deliver the prescribed thermal waveform(s) to at least oneof the vestibular system and the nervous system of said patient, whereinthe prescribed thermal waveforms are configured to maintain a vestibularstimulation that is sufficient to alter a vestibular phasic firing rateto thereby induce nystagmus over a period of more than three minutes.41. The vestibular stimulation system of claim 40, wherein saidphysician control device is configured to store said prescription in aprescription database residing therein.
 42. The vestibular stimulationsystem claim 41, wherein said vestibular stimulation device isconfigured to access the prescription database residing in saidphysician control device and to retrieve said prescription therefrom.43. The vestibular stimulation system of claim 40, wherein saidphysician control device is configured to transmit said prescription tosaid vestibular stimulation device over a wired or wirelesscommunications channel.
 44. The vestibular stimulation system of claim40, wherein said physician control device is further configured togenerate one or more thermal waveforms and wherein said prescriptioncomprises a set of instructions for delivering one or more of thethermal waveforms generated by the physician control device to at leastone of the vestibular system and the nervous system of said patient. 45.The vestibular stimulation system of claim 40, wherein said vestibularstimulation system further comprises a physician support deviceconfigured to generate one or more thermal waveforms, wherein saidprescription comprises a set of instructions for delivering one or moreof the thermal waveforms generated by the physician support device to atleast one of the vestibular system and the nervous system of saidpatient.
 46. The vestibular stimulation system of claim 45, wherein saidphysician support device is configured to store said one or more thermalwaveforms in a waveform database residing therein.
 47. The vestibularstimulation system claim 46, wherein said physician control device isconfigured to access the waveform database residing in said physiciansupport device and to retrieve said one or more thermal waveformstherefrom.
 48. The vestibular stimulation system of claim 45, whereinsaid physician support device is configured to transmit said one or morethermal waveforms to said physician control device over a wired orwireless communications channel.
 49. The vestibular stimulation systemof claim 48, wherein said physician control device is configured togenerate said prescription responsive to receiving/retrieving said oneor more thermal waveforms from said physician support device.
 50. Thevestibular stimulation system of claim 40, wherein said physiciancontrol device is configured to access a waveform database residing in adevice selected from the group consisting of a physician support deviceand a registry and to receive and retrieve one or more thermal waveformstherefrom.
 51. The vestibular stimulation system of claim 50, whereinsaid physician control device is configured to generate saidprescription responsive to receiving/retrieving said one or more thermalwaveforms from said device.
 52. The vestibular stimulation system ofclaim 50, wherein said waveform database resides in a registry thatcomprises thermal waveforms from at least one of one or more physiciancontrol devices and one or more physician support devices.
 53. Thevestibular stimulation system of claim 40, wherein said vestibularstimulation device is further configured to generate feedback data. 54.The vestibular stimulation system of claim 53, wherein said vestibularstimulation device is configured to store said feedback data in afeedback database residing therein.
 55. The vestibular stimulationsystem of claim 54, wherein said physician support device is configuredto access the feedback database residing in said vestibular stimulationdevice and to retrieve said feedback data therefrom.
 56. The vestibularstimulation system of claim 54, wherein said physician control device isconfigured to access the feedback database residing in said vestibularstimulation device and to retrieve said feedback data therefrom.
 57. Thevestibular stimulation system of claim 53, wherein said vestibularstimulation device is configured to transmit said feedback data to saidphysician support device over a wired or wireless communicationschannel.
 58. The vestibular stimulation system of claim 57, wherein saidphysician support device is configured to analyze said feedback data andto modify one or more of said one or more thermal waveforms responsiveto said analysis.
 59. The vestibular stimulation system of claim 58,wherein said physician support device is configured to store saidmodified thermal waveform(s) in the waveform database residing therein.60. The vestibular stimulation system of claim 59, wherein saidphysician control device is configured to access the waveform databaseresiding in said physician support device and to retrieve said modifiedthermal waveform(s) therefrom.
 61. The vestibular stimulation system ofclaim 58, wherein said physician support device is configured totransmit the modified thermal waveform(s) to said physician controldevice over a wired or wireless communications channel.
 62. Thevestibular stimulation system of claim 61, wherein said physiciancontrol device is configured to modify said prescription responsive toreceiving/retrieving said modified thermal waveform(s) from saidphysician support device.
 63. The vestibular stimulation system of claim62, wherein said physician control device is configured to store saidmodified prescription in said prescription database.
 64. The vestibularstimulation system of claim 53, wherein said vestibular stimulationdevice is configured to transmit said feedback data to said physiciancontrol device over a wired or wireless communications channel.
 65. Thevestibular stimulation system of claim 64, wherein said physiciancontrol device is configured to analyze said feedback data and to modifysaid prescription responsive to said analysis.
 66. The vestibularstimulation system of claim 65, wherein said physician control device isconfigured to store said modified prescription in said prescriptiondatabase residing therein.
 67. The vestibular stimulation system ofclaim 66, wherein said vestibular stimulation device is configured toaccess the prescription database residing in said physician controldevice and to retrieve said modified prescription therefrom.
 68. Thevestibular stimulation system of claim 65, wherein said physiciancontrol device is configured to transmit said modified prescription tosaid vestibular stimulation device over a wired or wirelesscommunications channel.
 69. The vestibular stimulation system of claim68, wherein said vestibular stimulation device is configured to deliverone or more thermal waveforms to at least one of the vestibular systemand the nervous system of said patient in accordance with said modifiedprescription.
 70. The vestibular stimulation system of claim 40, whereinthe physician control device is configured to generate the prescriptionby generating instructions for providing a plurality of spaced-aparttreatment sessions over a defined period of time.
 71. The vestibularstimulation system of claim 40, wherein the physician control device isconfigured to generate the prescription by generating an expirationtime, and prohibiting a delivery of the one or more thermal waveformsafter the expiration time.
 72. A vestibular stimulation devicecomprising: an earpiece; a thermoelectric device (TED) thermally coupledto said earpiece; and a controller operatively connected to said TED,said controller comprising: a prescription comprising a set ofinstructions for delivering one or more thermal waveforms to at leastone of the vestibular system and the nervous system of a patient; and acontrol module configured to activate said TED to deliver the prescribedthermal waveform(s), wherein the set of instructions for delivering oneor more thermal waveforms comprising the prescription includesinstructions for providing a plurality of spaced-apart treatmentsessions over a defined period of time.
 73. The vestibular stimulationdevice of claim 72, wherein the set of instructions for delivering oneor more thermal waveforms comprising the prescription includes anexpiration time after which the controller prohibits delivery of the oneor more thermal waveforms.